This is where you can find answers to the most frequently asked questions.


Progress report from the European Commission

Question: Have there been any updates on the progress of implementing the new regulation from any official sources?

Answer: Yes, in October 2018 the EU Commission published; the current MDR and IVDR implementing measures rolling plan, which includes the list of implementing acts to be published, and an updated state-of-play of joint assessments of Notified Bodies in the medical device sector.

Commissioner Elżbieta Bieńkowska also provided an update to the European Parliament on several topics, including the designation of Notified Bodies and the development of the European database. A recording is available on the European Parliament multimedia center. (Note: The debate starts at time 09:00 with Commissioner’s responses at time 09:05-09:11 and time 09:56-10:01).


Guidance from official sources

Question: Is guidance on the new regulation available from any official sources?

Answer: Yes, the European Commission has published a Fact sheet for Manufacturers of medical devices, a Step by step implementation model and an Exhaustive list of requirements for manufacturers of medical devices.

The Competent Authorities for Medical Devices (CAMD) have also published a Frequently Asked Questions specifically on the transitional arrangements MDD to MDR.


Help from the industry

Question: Is help available from the industry to understand the contents of the new regulations?

Answer: Yes, medtecheurope.org has published a poster sized overview of the new regulation >>> Click here <<<


New roles and activities such as Importers, distributors and making available on the market etc.

Question: Is additional guidance available on the new roles of “Importer” and “Distributor” and new activities like “making available on the market”?

Answer: Yes. However, these are not new roles and not new activities. Roles like Importer and Distributor and activities like making available on the market are not exclusive to the medical device and IVD sectors. They apply to virtually all industry sectors operating within the single market for products. This means, to properly understand the single market rules for products, one cannot rely solely on the limited mentions in the EU MDR/IVDR. They are defined in much greater detail, together with reference to legal acts, in the EU Commission’s “Blue guide” on the implementation of EU product rules.

(Updated Feb. 18) HPRA, the Irish Competent Authority, has also published a very comprehensive guidance specifically for distributers.


The additional five years conditional transition period #1

Question: Is it true that medical devices which conform to the current MDD can still be placed on the EU market after May 2020?

Answer: Yes. According to Article 120 (2-4), an additional conditional transition period is possible, but only for devices which still have a valid (MDD) Notified Body certificate in May 2020. Those devices can continue to be placed on the EU market and put into service as long their certificate is valid. This additional transition period is limited: Placing on the market date for MDD certified devices ends in May 2024, putting MDD certified devices into service ends in May 2025.

There are conditions: Not only must the manufacturer have a valid MDD certificate for the device. The manufacturer must also comply with the new EU MDR requirements for post-market surveillance, vigilance and registration.

To take advantage of the additional transition period, the manufacturer must renew their current MDD Notified Body certificate prior to May 2020. This option is not available to (MDD) Class I devices, the so called “self-declared” devices.


The additional five years conditional transition period #2

Question:

What is meant in Article 120, 3 by “the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives”.

Answer: Manufacturers can continue to use their MDD Notified Body certificates, on condition they update their post market surveillance, vigilance and registration procedures to those of the EU MDR by May 2020. It means:

(1) The MDD’s “institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase” (Annex II 3.1 or equivalent), is replaced by the EU MDR’s Articles 83, 84, 85 and 86 on “POST-MARKET SURVEILLANCE”.

(2) The MDD’s “notify the competent authorities of the following incidents immediately on learning of them…” (Annex II 3.1 or equivalent), is replaced by the EU MDR’s Articles 87, 88 and 89 on “VIGILANCE”.

(3) The MDD’s “Registration of persons responsible for placing devices on the market” (Article 14), is replaced by the EU MDR’s Articles 29 and 31 on “REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS”.


Language requirements for labels and instructions

Question: Have the language requirements for labels and instructions changed compared to the current MDD?

Answer: Yes. The MDD’s passive Article 4 (4) “Member States may require…” the information accompanying the device in national language(s), has been replaced by the EU MDR’s active Article 10 (11) “Manufacturers shall ensure…” the information accompanying the device is in national language(s).

Furthermore, the new EU MDR Annex I (23.1) also requires the information accompanying the device to be made available via the manufacturer’s website.


Have your question answered here

Post your frequently asked questions below.


 

191 thoughts on “Frequently Asked Questions (FAQ)”

  1. Is it true that NB-MED/2.12/Rec1 “PMS” and/or MEDDEV2.12-1 “Vigilance” are currently updated?
    If yes are the updates reflecting MDR requirements?
    Until when will the new versions become available?

    1. Thank you for the suggestions. Both topics are worthy of a FAQ once more information is available.

      Concerning NB-MED 2_12-1 on PMS, Rev. 11 is still the current revision according to the NB-MED documents listed on the Team NB website. While ISO TC 210 has started work on a Technical Report TR 20416 “Medical devices — Post-market surveillance for manufacturers”, at this time the best guidance is to follow the PMS plan content as described in the EUMDR Annex III 1.1 (a) and (b).

      Concerning MEDDEV 2.12/1 on Vigilance, Rev.8 is still the current revision according to list of guidance MEDDEVS on the Commission website. What is happening however is that a new Manufacturer’s Incident Report (MIR) form is being introduced. A timeline was published (on the ASSOBIOMEDICA website) last year. As recently as April this year MedTech Europe held a Webinar on the implementation. Ask your industry association more details or contact MedTech Europe directly.

  2. Dear Madam, Sir,

    September 2017 update of EU MDR regulations includes Base-UDI procedure. Where can I find information about Base-UDI (for product families)?

    Best regards,

  3. Thank you for your question about the European UDI format:

    In June 2019 the European Commission published IMPLEMENTING DECISION (EU) 2019/939 designating four entities to assign Unique Device Identifiers (UDIs) for medical devices for the European market. As European UDI/Barcodes differ from those in other regions, Manufacturers must choose one of the four designated entities to obtain the European UDI/Barcode numbers for their devices. The issuing entities can advise about the details of the UDI/Barcode. More information is available on the respective entities’ websites.

  4. Dear Madam, Sir,
    When a Notified Body that was previously certified under MDD is designated under the MDR will their Notified Body # change? If so will this new number be required to be included on the labeling?

    Best regards,

    1. Thank you for your question about notified body numbers changing:

      If the number of a notified body number changes, it must also change on the labelling and instructions where it accompanies the CE marking. However, the timeline for changing the number can usually be negotiated and agreed with the Notified Body concerned. To know if your Notified Body’s number is likely to change, ask your Notified Body’s representative or account manager. Concerning the four UK Notified Bodies, who are reportedly planning to transfer their Certificates to offices in the EU-27 in the case of a no-deal Brexit, it is anticipated that their Notified Body numbers will change if there is no Brexit agreement.

      Best regards

  5. When May 2020 rolls around, will submission of all post market surveillance activities be required for all devices on that date or is there a grace period to submit documentation for each medical device family?

    1. Thank you for your question about a grace period for submitting PMS information to EUDAMED:

      Concerning a “grace period” for submitting details of devices to EUDAMED, the MDCG has addressed this in its publication 2019-4. If EUDAMED is ready before May 2020, economic operators will be given 18 months to register the details of their devices in the database. If EUDAMED is not ready by May 2020, economic operators will be allowed 24 months from the date when EUDAMED is ready.
      Concerning post market surveillance documentation, EUDAMED will be used only by manufacturers of class III and implantable devices to upload the PSUR for evaluation by their notified body. Given that the PSURs for such devices have to be produced/updated annually, it seems reasonable to expect that the first PSUR uploaded to EUDAMED will be in May 2021 for legacy MDD devices, or for EU MDR compliant devices one year after the first device was placed on the market.

    1. Thank you for your question about a PSUR template:

      No, at least not as of March 2019. But a final draft version is being commented on and so it should be published soon.

    1. Thank you for your question about identifying an importer:

      Any product that is imported into the EU has an importer. That is already the case today. The concept of importer is not new and is not unique to medical devices. See the Commission’s “Blue guide” for more information. What the EU MDR introduces is that importers of medical devices must, in future, register themselves in EUDAMED and fulfil the obligations listed in Article 13, including having their name and address on the device.

  6. For devices that are Class I under MDD (e.g., software devices) and are currently being up classified, how long is the transition period to MDR. For example, if I self declare prior to May 26 2020, do I still have the same 5 year transition period as devices that receive MDD certificates prior to May 2020?
    Thank you in advance,

    1. Thank you for your question about the transition period for MDD Class I devices:

      The “Transitional provisions” of Article 120 are not available to MDD Class I devices because they don’t have a Notified Body certificate. Only devices placed on the market in compliance with the MDD “by virtue of”, or on the basis of, a Notified Body certificate are eligible for the additional transitional period. As MDD Class I devices do not have a Notified Body certificate they cannot take advantage of the transitional provision. As a result, regardless of their classification under the EU MDR, MDD Class I devices must either be fully compliant with the EU MDR by May 26th 2020 or be withdrawn from the EU market.

  7. If I’m planning to ship newly manufactured lots of product to the EU that have are CE marked under MDD in May 2020 and after, does the labeling/IFU need to comply with the MDR at that time or can I implement MDR-compliant labeling after receiving MDR certification?

    1. Thank you for your question about MDD compliant devices after 26 May 2020:

      MDD compliant devices (regardless of having a NB certificate or not) which are placed on the EU market prior to 26 May 2020 may continue to be made available on the market (i.e. further distributed, sold etc.) or put into service (i.e. used) until 27 May 2025. You don’t need to do anything additional for such devices. MDD compliant devices which are placed on the EU market from 26 May 2020 (on the basis they have a still valid NB certificate) can also continue to be made available on the market or put into service until 27 May 2025. This is explained in Article 120, para. 4.
      However, there are conditions to being able to continue to place MDD compliant devices on the market beyond 26 May 2020. Condition #1 The NB certificate for the device must still be valid (i.e. not expired). That excludes MDD Class I devices. Please note that there are limits to the continued validity of NB’s MDD certificates, either 2022 and 2024, depending on the certificate type. This is explained in Article 120, para. 2. Condition #2. In addition to continuing to fully comply with the NB certificate, the manufacturer must also fulfil the new EU MDR requirements for registration (Art. 29-31), vigilance (Art. 87-89) and post-market surveillance (Art. 83-86). This is explained in Article 120, para. 3.

      1. Hello eumdr.com!. Thank you as always for the useful advice.
        I need your additional advice regarding MDD compliant devices after 26 May 2020.
        I understood the manufacturer must also fulfil the new EU MDR requirements for registration (Art. 29-31), vigilance (Art. 87-89) and post-market surveillance (Art. 83-86). Also, regarding the labeling/IFU, you mentioned “no need to do anything additional” for the MDD compliant devices.
        How about accompanying multi language IFUs? Shall the manufacture comply with all MDR requirement of IFUs for the MDD compliant devices after 26 May 2020? Also, how about UDI label?

        1. Thank you for your question about legacy devices.

          For Directive compliant devices placed on the market before 26 May 2020, nothing additional is needed. Directive compliant devices can continue to be distributed and put into service until May 2025 (Art. 120 (4)). Therefore, your question is presumably concerned with so called “legacy devices”, placed on the market after 26 May 2020 by virtue of a valid notified body certificate issued prior to 26 May 2020 (Art. 120 (3)). Both the notified body certificate and the declaration of conformity for those legacy devices will state the devices conform to Directive 93/42, not to Regulation (EU) 2017/745. Making changes to legacy devices is still possible after 26 May 2020, including potentially to the labels and IFU. But any changes should be agreed with the notified body that issued the certificate and must not invalidate the conformity of those devices to Directive 93/42.
          Concerning the UDI requirements: The Medical Device Coordination Group Document MDCG 2019-5 makes clear that the UDI requirements in Regulation (EU) 2017/745 do not apply to legacy devices.

  8. Where do I find a requirements list to meet the new EU-MDR, when we talk about marketing materials (brochure, leaflets etc.).

    1. Thank you for your question about marketing materials:

      If by “leaflets” you mean the mandatory information that must accompany the device, the “instructions for use”, their content is specified in Section 23.4 of Annex I. In relation to promotional material there is only one explicit requirement in the EU MDR. That is, if CE marking/compliance is mentioned, the number of the notified body (if applicable) must also be stated (See Article 20).
      Concerning the (promotional) claims made for the device: In contrast to every other topic, the EU MDR doesn’t state what is required, only what is prohibited (See Article 7). Nevertheless, at minimum the Manufacturer will need a process to avoid doing what is described in Article 7, and the notified bodies will certainly be expecting to see that. Apart from that, we are left with interpretation: Annex XIV says the clinical evaluation must be appropriate, not only to the intended purpose, but also to the claims made for the device. Likewise, Annex XV says that the clinical investigation should also confirm or refute the manufacturer’s claims. This implies that the claims made for the device must be consistent with the clinical data, and by extension the risk analysis – that’s nothing new. Nevertheless, this is confirmed when one looks at the requirements for the notified body in Annex VII. When reviewing the manufacturer’s clinical evaluation, the notified body is required to consider not only the stated intended use, but also the claims made for the device. But that’s really as much as is said about claims and promotional material in the EU MDR.

  9. For few of Medical Devices which is manufactured before May 2020 as per MDD & need to provide the spare parts for those devices at least for next 15 years so in that case is it required for the component manufactuer to meet the MDR requirements else, can it be as per MDD

    1. Thank you for your question about parts and components:

      Article 23 on “Parts and components” introduces a new documentation requirement for entities that supply replacement parts or components for medical devices. Given that there is no qualification on when the device being repaired was put first into service, it follows that the article applies to parts and components intended for any medical device which is still in service, regardless of when it was first put into service. Important to note however that this article applies to items “specifically intended” to replace a part or component of a device. Implying that the Article is probably not intended to be interpreted as applying to suppliers of parts and components in general, only those specifically intended for use in a medical device.

  10. Hello, This is Kim from South Korea.
    I am a RA staff of a medical device company. and have a question about MDR`s Language requirements for labels and instructions.

    As we know, MDR will be enforced in may next year and we have already applied. but there is an issue at the IFU.
    Do we have to write the IFU in 24 EU offical languages?

    EU MDR’s active Article 10 (11) “Manufacturers shall ensure…” the information accompanying the device is in national language(s). –> I have no idea Medical device manufacturers have to write IFU in 24 EU offical languages
    Is it compulsory? and Is it realistically possible?

    I`d like to ask you this because It is hard to solve.
    Thank you for your cooperation.
    Best Regards,

    1. Thank you for your question about the languages needed for instructions:

      As you point out, Article 10(11) “Manufacturers shall ensure that the device is accompanied by the information… in an official Union language(s) determined by the Member State…” is a significant change from Article 4(4) of the MDD “Member States may require the information… to be in their national language(s)”. Furthermore, Article 14(2b) makes it an obligation of EU Distributors, for any medical devices they intend to distribute, to verify that the Manufacturer has complied with that particular obligation.
      However, there is no obligation to make a device available in all Member States or in all EU languages. Manufacturers must decide in which Member States they intend their device to be available and in which languages the instructions need to be made available. The EUMDR also allows Manufacturers and Distributors different options: Article 23(1) allows in; (d) for Class I and IIa devices to be supplied without instructions if the device can be used safely without them, (f) the use of non-paper formats, (h) the use of internationally recognised symbols. Whereas, Article 16(2a) allows Distributors to translate and supply the instructions provided by the Manufacturer, as long as the Distributor has a quality management system.

      1. We are a distributor of a medical device which is imported from non-EU manufacture through an importer.
        Hello eumdr.com.
        I have an additional question regarding your comment which is “Whereas, Article 16(2a) allows Distributors to translate and supply the instructions provided by the Manufacturer, as long as the Distributor has a quality management system.”.
        I think that above case is “the translation is by the distributor”.
        Here is our case. Our manufacture accompanies only English IFU with a product. Also, our manufacture provides us translated IFUs in other languages by PDF files. When we print the PDF file and provide the hard copy to a customer with the product, is Article 16(2a) applied?
        In addition, eIFU can not be applied for our product because our product is NOT “fixed install medical devices” and does not have a function to display IFU.

        1. Thank you for your question about Article 16.

          As a medical device distributor your company is responsible for its own interpretations of the regulation. As you point out, according to Article 16 paragraph 2, there are activities which “…shall not be considered to be a modification of a device…” and in 2 (a) “provision of the information supplied by the manufacturer” is given as one such an example. Nevertheless, while Article 16(1) might not apply to such an activity, the requirements of both paragraphs 3 and 4 have to be met by importers and distributors who perform the activities in paragraph 2 (a) and (b). This is explicitly stated.

  11. Could there have been a typo error on the Guidance document, where it says that the updated version of the MIR form that will become mandatory from January 2020 is version 7.2 ? The European Commission’s Document Room posts version 7.1 as the new MIR form, and it already includes section for UDI, which we all know is required under the new EU MDR. Should it have been 7.1 and not 7.2? Or is there an MIR version 7.2 that’s yet to be published?

    1. Thank you for your question about the new Manufacturer’s Incident Report (MIR) form:

      The current version of the new Manufacturer’s Incident Report (MIR) form is version 7.1. In referencing version 7.2, the new additional guidance on MEDDEV 2.12/1 rev.8 (published in July 2019) appears consistent with the MEDDEV Guidance page. You can find there several .xsd files together with the note “for implementation in manufacturers databases before January 2020”. This strongly suggests, together with the new guidance, that there will be a new, new Manufacturer’s Incident Report (MIR) form before the end of 2019.
      See page https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

  12. Can you be certified to the MDD and to the MDR in parallel? More specifically, if your devices are re-certified under the MDD can you submit a new device technical file for review under the MDR or does that trigger a full blown transition to MDR?

    1. Thank you for your question about the transition period.

      There are always two certifications to consider: The Quality Management System certification of the Manufacturer and the CE (notified body) certification of the device.

      Currently, Manufacturer’s quality management system certificates should show conformity to EN ISO 13485:2016 + Annex ZB (MDD). There will be a new Annex Z for the EUMDR in due course, but for the time being EN ISO 13485:2016 + Annex ZB should be sufficient for both the MDD and the EUMDR, regardless of whether the manufacturer is placing legacy MDD compliant devices on the market, EUMDR compliant devices, or both.

      However, a device can only conform to either the MDD or the EUMDR. It depends what is claimed on the Declaration of Conformity, 93/42 or 2017/745. According to Article 120, legacy MDD devices with an existing certificate can continue to be placed on the market according to the MDD after May 2020. They will also be registered in EUDAMED as a “legacy device”. There are several conditions associated with Article 120 which are dealt with elsewhere on this site and in other Q&As. So, until a new MDR notified body certificate is obtained for a device, the declaration of conformity is updated and the device is registered in EUDAMED as an EUMDR compliant device, the device continues to be a legacy MDD device. An application to a notified body to assess technical documentation has no effect on the status of an already marketed device.

  13. Is the Importer different than the distributor or can be the same company?
    Does the Importer needs to physically handle product coming from abroadprior to release them to EU distributors or products can be stored by a logistic company anr then released to distributors, in this case still need an Importer ?

    1. Thank you for your question about Importer obligations.

      The best reference defining the different economic operators is the Commission’s ‘Blue Guide’ (2016/C 272/01). That said, it seems likely that all importers will be distributors, simply the first distributor in the supply chain within the European Union. Importers do not release devices as manufacturers do. The importer’s obligation is to verify the conformity of the devices they will be making available on the EU market. Given that this verification concerns documentation, not product testing, there would seem to be no reason why an importer should need to have physical possession of the devices concerned.

      1. I have a question regarding your comment for ” Importer obligations”. It seems that an importer should NOT need to have physical possession of the devices. However, in Article 13(2)(a), importers shall verify that the device has been marked CE. Also, in Article 13(2)(c), they shall verify that the device is labelled and accompanied by the required instruction for use. How can importers verify those requirements without physical possession of the devices. Is it necessary to verify them by visual inspection with opening packages of the devices?

        1. Thank you for your question the compliance verification by the importer.

          This question is not answered in the regulation. However, given that manufacturer and importer have a business relationship, they have the possibility to agree how the verification will be performed by the importer. Whether by the manufacturer supplying or providing access to the necessary documents, or by physical inspection.

  14. I have a question about requirements (23.1) in Annex I.
    According to 23.1, it requires the information accompanying the device to be made available via the manufacturer’s website.

    Question:
    Our company has a MDD compliant device (class II) of which the EC certificate is valid until 2023,
    do we need to upload the information on the webstie by 2020/5/26 and keep it up to date from then on ?

    Or the requirements in (23.1) just necessary for MDR compliant device?

    Thanks in advance.

    1. Thank you for your question about posting legacy device labelling online.

      After 26th May 2020, manufacturers may continue to place their legacy MDD devices on the EU market in accordance with Article 120 (2-4). In addition to having a valid MDD certificate, such manufacturers must also comply with the post market surveillance, vigilance and registration procedures of the EUMDR. That is; Articles 83, 84, 85 and 86 related to post market surveillance, Articles 87, 88 and 89 related to vigilance, and Articles 29 and 31 on registration. But those are additional obligations relate to the manufacturer’s QMS. The device itself is still being placed on the market in conformity with the MDD. That means, for the legacy (MDD) Declaration of Conformity and legacy (MDD) EC certificate to remain valid, the device itself must continue to conform to the MDD, including Annex I of the MDD. Annex I of the EUMDR doesn’t apply to legacy devices. However, manufacturers can make their labelling available to users via the internet at any time, including the labelling of their MDD compliant devices. There is nothing to prevent it. It’s simply not a requirement for legacy devices.

  15. I have a question about classification of the products

    Some general surgery surgically invasive instruments are used in general surgeries and in open heart surgeries as well i.e. Hemostatic Forceps & Surgical Scissors etc.

    These Reusable Products are classified under Rule 6, Class IR (Surgically Invasive)

    These Single Use Products are classified under Rule 6, Class IIa (Surgically Invasive)

    In MDR we use same classification for these devices? Or due to usage in open heart surgery these instrument’s classification will be changed into class III?

    1. Thank you for your question about classification rules:

      Annex VIII, 3.5. says “If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device’s intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.” If, however the manufacturer cannot decide the appropriate classification, they (or their authorised representative) should contact their competent authority and request a classification decision (Article 51, 2).

  16. Can a company begin updating and implementing quality processes, WI’s, checklists, tech files, eIFU’s et cetera now, to include MDR requirements (e.g. start citing MDR within docs) even though they are not yet certified and won’t be up for recertification until a year after the MDR goes into effect?

    1. Thank you for your question:

      Probably the only document that needs to directly reference the EUMDR is the EU Declaration of Conformity. Nothing prevents a manufacturer from incorporating requirements from the EUMDR into quality system documents at any time. According to media accounts there are manufacturers who are ready to submit applications under the EUMDR, but they cannot because of the lack of notified bodies. That implies their quality management and technical documentation is already EUMDR compliant, even though they are continuing to place devices on the market with MDD certificates.

  17. Hi! Could you please clarify par. 4 Article 27: “UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers.”
    What does MDR mean under the shipping containers – carton box with some amount of the devices or freight metal containers? What is the highest level of packaging in the case of manufacturing dermal fillers for example?

    1. Thank you for your question:

      An industry association would typically be the best forum in which to reach a consensus position for a specific group of devices. That said, generally speaking, the EUMDR requires the UDI to be placed on packaging intended for the users, not on packaging created purely for logistics or distribution purposes.

  18. I understand some MDD Class I devices have CE certificates involving notified bodies, such as;
    – manufacturer choose to be certified by NB to increase market credibility
    – device is sterilized (Class Is), or measurement device (Class Im)
    In cases like above, can the certificate be valid until 27 May 2024 maximum? (Article 120-2)

    1. Thank you for your question:

      Article 120 only mentions certificates issued by notified bodies. There is no mention of device classification. Article 120 is valid for all notified body certificates regardless of the device’s classification.

  19. In the case a Medical Device manufacturer sell a MD before 2020, but his certificate MDD is expired, con I continue to put on the market the Md (if the Md was produced when the certificate was still valid)?

    1. Thank you for your question:

      A manufacturer must not supply a device to anyone within the EU if the MDD certificate for that device has expired. But if the MDD certificate was valid when the device entered the EU distribution chain, the device can continue to be distributed or used even if the MDD certificate subsequently expires.

  20. As I underestood, for active implantable devices, the UDI-PI shall include at least the serial number, for other implantable devices, the serial number or lot number. Our device belongs to class III implantable devices, however has ability of resorption 90 days after implantation. My question is that do we have to consider it as active implant and there is a need of serialisation, or because of obsorption it is considered as other (not-active) implant and lot number would be enough for labelling.

    1. Thank you for your question:

      The definition of “active device” is found in Article 2 (4). Generally speaking, an active device is one that depends on a source of energy. If there is no source of energy the device is unlikely to be an active device. However, the classification of the device in question must be performed systematically applying the definitions and rules contained in Annex VIII.

    1. Thank you for your question about distributors.

      The obligations of distributors are listed in Article 14: Distributors are required to verify some elements of the labelling and instructions as well as the EU declaration of conformity. But distributors are not required to review the technical documentation.

  21. It is stated at Annex I, Chapter III, subsection 23.2. Information on the Label; “(d) if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative.” what is the definition of the “Union” here? if it means only the European Union members, for the manufacturers registered at Swiss, they need represetative. If the “Union” is defined as both 28 EU members and the members of the European Free Trade Association (EFTA) which Swiss is included, then they do not need representative. Could you please clarify the definition of the “Union”.

    1. Thank you for your question.

      For a full definition of the applicable geographies, please read the European Commission guidance, the “Blue guide”. >>>> link here <<<<.
      Concerning Switzerland, additionally there is the EU-Swiss mutual recognition agreement on conformity assessment which includes medical devices. >>> link here <<<.

  22. Currently, we are preparing for MDR certification. But our MDD certficate is valid until 05/2020 and certified by UK Notified Body, and the Brexit will happen on 30/10/2019. Is it possible for us to place our products into the EU market within this timeline, and for products which are already placed on the markets, what is the timeline for them put into service?

    1. Thank you for your question about Brexit.

      Please refer to the European Commission guidance on this topic. >>> link here <<<
      In brief: If there is a withdrawal agreement, your company can continue to place its devices on the EU market after the Brexit date on the basis of their UK notified body certificate, until the end of the withdrawal agreement. Whereas, if there is no withdrawal agreement, the so called “no deal”, your company cannot continue to place its devices on the EU market after the Brexit date on the basis of their UK notified body certificate. Only with a certificate issued by an EU-27 notified body. However, concerning devices already placed on the EU market before Brexit, they can continue to be put into service until 27 May 2025 (depending on shelf life). Please read EUMDR Article 120(4).

  23. I am looking for some guidance on interpretation of the wording in Article 88 Trend Reporting:
    “any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis”

    Does “that could have a significant impact on the benefit-risk analysis” apply to both Non-serious and expected undesirable side-effects or just incidents expected undesirable side-effects?

    1. Thank you for your question.

      The latter. It only applies to the expected side-effects. This is also stated in the preamble, whereas (81).

  24. hi, Do we need to have identification labels such as name, manufacturer on an accessory supplied with a system ? is it mandatory to have them on the accessory when it falls under UDI of system ?

    1. Thank you for your question about accessories.

      The regulatory status of accessories in the EUMDR is the same as it was under the MDD. If your product fulfils the definition of an “accessory for a medical device” given in Article 2(2), according to Article 1(1), the regulation applies and all of the requirements applicable to devices apply to your product, including the UDI requirements.

  25. Regarding “The additional five years conditional transition period #1” & “Article 16”.
    MDR requires QMS for accompanying IFU after Place on the market, but is it the same for class II products that continue to be certified by MDD?

    1. Thank you for your question about authorised representatives.

      Independent of whether the device being imported or distributed is a legacy MDD device or an EUMDR compliant device, the obligations of authorised representatives, importers and distributors apply from 26 May 2020.

      1. Please reconfirm the statement above that that obligations of authorised representatives apply from 26 May 2020. Does that mean all authorised representative contracts need to be revised to MDR requirements by 26 May 2020 for legacy MDD devices?

        1. Thank you for your question about the date of application.

          According to paragraph 2 of article 123, the date of application or mandatory implementation date of the regulation is 26 May 2020. There are exceptions or derogations for quite a number of Articles listed in paragraph 3, but Article 11 on the Authorised Representative is not one of them. Neither is Article 11 mentioned in the transitional arrangements in Article 120. Therefore, the date of application for Article 11 is 26 May 2020.

  26. Hi,
    Could you please give examples of medical device softwares that fall under Class I of MDR?

    MDCG 2019-11 Guidance has the following example, but it is unclear why is this not classified as Class IIa under MDR Rule 11 b?
    “MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm. The user inputs health data including basal body temperature (BBT) and menstruation days to track and predict ovulation. The fertility status of the current day is reflected by one of three indicator lights: red (fertile), green (infertile) or yellow (learning phase/cycle fluctuation). This MDSW app should be classified as class I per Rule 11c.”

    1. Thank you for your question about software classification:

      Concerning the fertility status app: One would have to know the intended purpose of such an app, but it seems unlikely that it would be intended to make “decisions with diagnosis or therapeutic purposes” which is the main qualifying criteria for devices to be in class II or III.

      Concerning examples of class I software functions: Given that both the European Commission and the FDA are members of the IMDRF and before that the GHTF, the FDA’s website may be a useful benchmark. FDA has published a list of examples of mobile apps which FDA considers are not medical devices. FDA has also published a list of examples of medical device software functions which FDA considers to be low risk.

      1. It’s maybe worth restating that the classification of any device, including software devices, should not be performed in isolation. The following approach may help to eliminate those software functions that are not a medical device, and to differentiate between those that are intended to be used in clinical decision making (i.e. Class II or III) from those that are not (i.e. Class I).

        1 – First define and document the intended patient population and medical conditions to be diagnosed, treated and/or monitored by the device;
        2 – Then define and document the principles of operation of the device (not technically but medically), and the mode of action by which the device achieves its intended purpose of diagnosing, treating or monitoring the medical condition in the intended patient population. In the case of software, consider the intended users and whether or not the software function is intended to be used in making clinical decisions such as deciding whether or not to treat, diagnose or monitor the condition etc.;
        3 – Next, decide and document the rationale why the product qualifies as a medical device – not all software used in the health and wellness arena fulfils the definition of a medical device as the examples on the FDA website illustrate;
        4 – Finally, decide the risk class and document the justification for the classification rule(s) considered applicable.

        1. Are you suggesting that the EU will accept a general wellness designation based upon FDA guidance? Where can I find this in the regulations? I have several general wellness features that my company wants to explore EU classification. Where can I find these carve outs in the MDR or European regulations?

          1. Thank you for your follow-up question.

            The decision on the classification of your software is your decision as the manufacturer. Of course, you must apply the rules in Annex VIII and document your justification in the Technical Documentation, as specified in Annex II 1.1 (f). But the classification is your decision.
            Rule 11 of Annex VIII allows medical device software to be classified in any of the four classes; III, IIb, IIa and Class I. While MDCG 2019-11 is primarily concerned with medical device software in Classes III, IIb and IIa, it does contain one example of a Class I medical device software.

  27. I have a Class II device that is MDD certified that we’ve decided to discontinue manufacturing and selling prior to our MDD certificate expiration. This device will not be recertified to MDR. Can we continue to repair the MDD-certified device and return it to the field after 26 May 2025? (Note, we are not refurbishing, just repairing)

    1. Thank you for your question about maintenance activities.

      Your devices were placed on the market according to the MDD, which didn’t address maintenance activities. The EUMDR doesn’t address maintenance activities either, as such, but it does place obligations on the suppliers of replacement parts and components intended for that purpose. Please read Article 23 in case it is applicable.

      1. Regarding the above, how about if we still have product in the field that we would continue to be responsible for repairing in regards to vigilance? Should we keep our Authorized Representative, and put reporting timelines in our procedure per ISO 13485:2016 8.2.3?

        1. Thank you for your question about vigilance requirements under the MDD.

          Publication MEDDEV 2.12/1 rev. 8 contains the guidance on vigilance under the MDD. MEDDEV 2.12/1 was updated in July 2019 when additional guidance published. That additional guidance was followed by the introduction of a new MIR (Manufacturer’s Incident Report) which became effective in January 2020. Please consult the European Commission website for the latest guidance.

  28. Hello, we are a UK device manufacture, we have a product which is covered by MDD. Our supplier has ceased providing parts, so we placed a final order and manufactured two years of stock. The MDD compliant stock is now on the shelf in our warehouse ready for sale. We will discontinue the product once stock runs out. When MDR applies in May 2020 we are covered by our MDD certificare, however we are having a debate about what constitutes a device being ‘placed on the market’. The 2 years worth of stock on the shelf was manufactured pre May 2020 under MDD, and is ready for sale. After May 2020 can we consider this stock to be classed as ‘placed on the market’ and continue to sell it freely.

    There has been some debate about terminology of ‘placed on the market’ and the use of the word ‘transfer’ for sale….please can you advise.
    Thankyou in advance

    1. Thank you for your question about placing on the market.

      Placing on the market includes the transfer of ownership, for example from the manufacturer to a distributor or a user. If the products are still owned by the manufacturer they have not been placed on the market. Please read section 2.3 of the European Commission’s ‘Blue Guide’ on the implementation of EU products rules.

  29. Regarding Article 120

    Hello, I’d like to confirm what we have to do for MDD legacy products.

    Article 120 states that:
    ”However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”

    In case of above, does the importer need to do that described in Article 13 for MDD legacy products?
    “Article 13 2. In order to place a device on the market, importers shall verify that:
    (a), (b), (c) and (d). “

    1. Thank you for your question.

      Article 120(3) is addressed to manufacturers, Article 13(2) is addressed to distributors. Both requirements will apply from May 2020 but they will apply to different types of companies. Which requirements apply to your company depends on the role the company has, manufacturer or importer.

      1. Hello,

        What part of the requirements for importers and distributors as articulated in the MDR, are applicable also for legacy MDD devices that are placed in the market from May 2020 onward ?

        thank you.

        1. Thank you for your question about importers and distributors of legacy devices.

          The obligations of importers and distributors apply from 26th May 2020, independent of whether the devices being imported or distributed are new (MDR) devices or a legacy (MDD/AIMDD) devices. There is one item which is not applicable to legacy devices, legacy devices are not required to have the UDI (Article 13, 2(d) and Article 14, 2(d)), but the manufacturer should inform the importer or distributor about that in the course of the verification. As far as importers and distributors are concerned, all of the obligations should be fulfilled regardless of the devices being imported or distributed.

  30. If we continue to sell out class II products under the MDD until 2024, will the labeling need to be compliant to the MDR requirements at the May 2020 date?

    1. Thank you for your question about legacy devices.

      No. If after May 2020 your company continues placing devices on the market on the basis of an MDD certificate, they must remain in compliance with the MDD.

  31. We have some class I devices that we manufacturer outside Europe. Will it be possible to manufacture a “safety stock” of them and have at our warehouse in EU and be able to sell them after May 26th 2020? That would give us 1-3 months extra to update the documentation to MDR.
    Would it be possible if the class I products produced before May 26 2020 was placed at the distributors or at our sales offices in EU?
    We have not been able to find guidance of this specific issue anywhere.
    Thanks in advance

    1. Thank you for your question about placing on the market.

      Absolutely possible. The condition, according to Article 120 (4), is that they are placed on the market prior to 26 May 2020. Meaning, ownership of the devices is transferred from the manufacturer or importer to a distributor within Europe. If that is the case, they can continue to be made available to other distributors or to end users until 27 May 2025.

  32. Hi,

    Our class 3 active medical implant certificate expires in mid-2021. My question is similar to that of @Terese, can I build up a safety stock and transfer ownership to the distributor? And the distributor will be able to sell the devices until 27 May 2025?

    Can I transfer ownership of the devices to the distributor prior to the certificate expiring mid-2021 or would I have to do it prior to 26 May 2020?

    Thank you very much,
    Kamil

    1. Thank you for your question about legacy devices.

      Your question suggests you are a manufacturer of a legacy device which has a valid notified body certificate. In that case you don’t have to adopt the approach of the questioner with the class I device. Article 123(3) allows you to continue placing your device on the market, just as you do today, until the expiry of the certificate. Taking advantage of Article 120(3) is conditional on not making any significant changes which would invalidate your legacy certificate, and also on you implementing the registration, vigilance and post market surveillance requirements of the EU MDR. Alternatively, if you choose not to take advantage of Article 123(3), you have the same option of following Article 120(4) as the class I device manufacturer and placing additional devices on the market until May 26th, after which they can continue to be put into service until May 2025.

      1. Hello eumdr,

        Where can device manufacturers find guidance on what are considered “significant changes” as stated in Article 120(3)? Can we continue to use our MDD significant change interpretation for the MDR as well?

        Thanks,
        Apeksha

        1. Thank you for your question about significant changes.

          Several of the industry associations collaborated in 2019 on a document titled “Joint Industry Position on Significant Changes According to MDR Article 120(3)”. But if your company already has a procedure based on the NBOG best practice guide, for deciding when to inform the notified body of planned changes to the product, you should continue to follow that procedure. In case of doubt you should discuss the planned change with your notified body.

  33. Dear eumdr.com,

    I need some help regarding obligation of distributors mentioned in article 14.2.

    If a distributor wants to place an MDD certified (legacy) device on the market after 26-May-2020, should he verify that the labelling and IFU of that device is in an official Union language(s) determined by the Member State? Or is the Article 4(4) of the MDD “Member States may require the information… to be in their national language(s)” still valid?

    Moreover, is the obligation mentioned in 14.2 (b) referring to only instructions for use or text on the label too?

    Thank you in advance.

    Kind regards.

    1. Thank you for your question about distributors obligations.

      Strictly, distributors do not place devices on the market. Distributors make devices available which have already been placed on the market by the manufacturer (or importer). The manufacturer has the obligation to ensure the device is compliant when it is placed on the market.

      While Article 14 doesn’t address the potential differences with legacy devices, those differences are limited to paragraph 2. (b), (c) and (d). All the other distributor obligations are independent of whether the device is a legacy or MDR compliant device. If a distributor is unsure of the language requirements applicable to a legacy device they are distributing, they can enquire of the manufacturer or their national competent authority.

  34. There is no confusion that syringe is a medical device.
    In case of an empty or pre-filled syringe, do the rubber stopper in the barrel of syringe also qualifies the definition of “accessory” as per MDR 745 and it is considered as medical device or not???? Rubber stopper / component itself is not a medical device. In practice empty barrels of syringes and rubber stoppers are manufactured by different manufacturers.

    1. Thank you for your question about parts or components.

      An assembled syringe is only a medical device if it is intended by its manufacturer to be used for a medical purpose. Syringe barrels and plungers on their own have no intended medical purpose (e.g. Annex II, 1.1 a, c, d, etc.) and therefore cannot be either medical devices or accessories. They are parts or components.

  35. Hi,
    I need certain information about transition period of Class I medical device.
    We have Class I medical device according to MDR. Other classifications are clear. For example Class IIb or Class Ir until May, 2024. These are Notified Body approved products.

    What is the last date of Class I Medical device according to MDD?
    Thank you in advance.

    1. Thank you for your question about transitional provisions.

      As you wrote, the Article 120(3) transitional provision for legacy (AIMDD/MDD) devices applies to devices which, under the EU MDR, require the involvement of a notified body. In the situations described, the manufacturer of such legacy devices, including legacy Class I devices, may make use of the transitional provision and continue to place their legacy device on the market until 26 May 2024. However, it is not the case for devices which do not need the involvement of a notified body under the EU MDR. Article 120(3) does not apply to such devices.
      The transitional provision applicable to such devices (i.e. MDD Class I devices which under the EU MDR do not need a notified body) is Article 120(4). The latest date for placing such MDD Class I devices on the market is 25th May 2020. After that date they can continue to be made available on the market via distributors, or put into service by users, until 27 May 2025.

  36. Hi there, good morning.

    it is clear about the implications of the MDR2017/745 upon May 25th, 2020 when we think about Quality Management System, Product Registration and so on.

    My question is specific about implications of such MDR in the service perspective:
    when is the deadline to have service/support activities (installations, repairs, maintenance) in place and compliant with MDR 2017/745?

    Many thanks for considering my request.

    1. Thank you for your question about post installation servicing.

      The requirements for the provision of service, including installation, are given in ISO 13485. Apart from introducing new requirements for parts and components (Article 23), the EU MDR does not regulate the provision of service.

      1. Thank you for your answer.

        I see that you updated the reply with the bold part (post installation servicing). I am impressed how good your control with the information/news and forum is. Great!
        If relevant to be known and introduce into an internal process, what is now different and what would you mean then with “pre installation servicing” or even “installation servicing”?

        As far as I could check so far, the requirements given in ISO 13485 are important to keep the medical device well installed and maintained.

        For your attention, I say thanks a lot.

        1. Thank you for your feedback.

          If a medical device requires installation or post-installation service/support, that should be included in the scope of the applicable quality management system. ISO 13485 says “service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specification”. Meaning, the QMS principles of plan-do-check-act can and should be applied to service activities in the same way as to production activities.

  37. I seek some clarity regarding Basic UDI, UDI-DI and how the technical documentation will be compiled. Basic UDI will be assigned to a group of products with similar intended purpose, risk class, manufacturing characteristics etc. UDI-DI on the other hand, will be assigned to each model/version of that product group. Multiple UDI-DI can be assigned under one Basic UDI.
    Making Basic UDI as base, can we develop one technical file and in it cover all types of products for which we have assigned separate UDI-DI (Single use, Reusable, Sterile, Non-sterile) rather than creating separate files of products as was previously done, particularly for single use and reusable products.

    1. Thank you for your question about technical documentation.

      The EU MDR does not regulate such specifics. Annex II details what Technical Documentation is to be kept available for each device, but not how. Only that it should be presented in a clear, organised, readily searchable and unambiguous manner. The manufacturer has to decide what is appropriate for their specific device or devices.

  38. Regarding Article 120.
    Are there any exceptions for a (MDD) Notified Body approved class IIa product that will fall within MDR Article 1(6)h, or are the Article 120 transitional provisions fully applicable?

    1. Thank you for your question about the scope of the EUMDR.

      If according to Article 1(6) a product is outside the scope of the EU MDR, it cannot benefit from the transitional provisions in Article 120.

  39. Hi,
    Can you please give guidance on the following scenario:
    We are an EU based importer of Class IIb medical devices manufactured in a third country. The devices are currently covered by a MDD certificate that expires May 2021 and we expect the manufacturer to be compliant with the MDR on DOA. If we order 20,000 of these medical devices on 21 May and a further 20,000 on 21 June 2020 and these are manufactured in 4 lots i.e. 10,000 as Lot A on 24 May 2020, 10,000 as Lot B on 10 June 2020 and 20,000 as Lot C on 15 July 2020 and these are all supplied to us on 20 July 2020 for distribution into EU do we need to record on device label or packaging or on information with the devices our details as importer on Lot A and/or Lot B and/or Lot C ? In addition do any of Lot A or Lot B or Lot C need to indicate they are Medical Devices on the label?
    Thanks.

    1. Thank you for your question about importers and distributors of legacy devices.

      The obligations that apply to importers (Article 13) from 26th May 2020 are independent of whether the device is a legacy MDD device or an MDR compliant devices. They are also independent of when the device was manufactured or imported into the EU. Any device which is made available by an importer from 26th May onwards, must have been verified as being compliant (paragraph 2) and indicate the importers identity (paragraph 3).

    1. Thank you for your question about the language of the QMS.

      In addition to IFU and labels, the EU Declaration of Conformity must also be translated into the languages of the countries in which the device is made available (Article 19). Concerning the QMS, the EU MDR does not regulate the language used in the QMS documents. Nevertheless, of necessity, the QMS documents must be understandable to the persons (employees or contractors) who have to apply them.

  40. Hello, i’m writting on behalf of a medical device legal manufacturer.

    we already have a quality agreement signed with a distributor, and we have a little doubt regarding the article 16 (3) & (4).

    If our distributors replace the labelling or package of the medical device due to they are in bad conditions, is it understood as a relabelling or repackaging of the device?

    1. Thank you for your question about repacking damaged goods.

      The activity you describe above is different from the specific activities described in paragraph 2 (a) and (b). But if this is a specific concern, perhaps you should consider also including the rules for dealing with damaged goods in your quality agreement with your distributor.

  41. Hello,

    Article 27(7) states that as part of technical documentation referred to in Annex II, the manufacturer shall keep up to date a list of all UDIs that it has assigned. However, Annex II only requires Basic UDI-DI to be listed within technical documentation. Is the expectation that all full UDIs (UDI-DI + UDI-PI) will be maintained within technical documentation, or can UDIs be maintained separately?

    1. Thank you for your question about UDIs listed in the technical documentation.

      The Basic UDI-DI or BUDI-DI referred to in 1.1b is not a unique device identifier but the global model number or equivalent. If that is not clear, please consult your UDI code-issuing entity.
      Prior to the conformity assessment and production start, there will presumably only be a list of planned variants, together with their respective (planned) UDI-DIs. After conformity assessment and production start there will presumably be, in the production records, a list of the actual UDI-PIs.

  42. Hi everyone,

    I would like to hear your comments on the implementation of Article 16(4). More specifically, this part:

    “Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.”

    I am exploring the options for obtaining this aforementioned certificate from a notified body. For example, if we are providing translation of the labelling to the national language, we would fall under this requirement (provided that we don’t make any changes to the original).
    What would be the way to obtain such certificate? Does this mean that ISO 13485 should be implemented? Isn’t ISO optional? Is there any other option to obtain this certificate? How would you solve this issue?

    Thank you for you help.

    1. Thank you for your question about notified body certification of importers/distributors.

      The EU MDR does not address this topic specifically. Notified bodies will have to establish procedures for this and it might be, until a common approach is agreed between notified bodies and competent authorities, that ISO 9001 or ISO 13485 certification will be the current best solution. You are recommended to continue discussing with the notified bodies.

  43. Hello,

    Our manufacturing site and our head office will change this summer. we have informed our notified body of this planned change. It consider that it is not a significant changes” as stated in Article 120(3) because this change don’t affect the product conception and the intended use. However, it doesn’t know if our next audit can be made according the MDD directive because, it doesn’t know if it can make an addendum of this certificate (situation described in the document “Joint Industry Position on Significant Changes According to MDR Article 120(3)” –> However, these non-significant changes may require an amendment of the existing valid AIMDD or MDD certificate, to reflect properly the actual status of the device or manufacturer after the change).
    Do you think this relocation could invalidate our MDD certificat because our notified body could not emit an addendum to our existing certificate? Is the MDR regulation is so restrictive on this subject: the update of valid certificate?

    What do you think about this situation and which solution are possible?

    Thanks
    Virginie

    1. Thank you for your question about changes affecting legacy devices.

      The EU MDR does not address this topic. Any limitations on amending legacy MDDs certificates most likely come from the Notified Body’s own internal procedures, or agreements it has made with its Competent Authority or the Notified Body Operations Group. Your Notified Body is the best organisation to answer your question.

  44. Question on managing clinical supply of investigational devices supporting clinical trials under the new MDR. Is the manufacturer and/or depot distributing the investigational device to clinical sites required to have a Qualified Person responsible for QP certification similar to clinical investigational medicinal product (IMP)?

    1. Thank you for your question about clinical supplies management.

      Although greatly expanded compared to the Directives, the EU MDR’s requirements for conducting clinical investigations (Articles 62-82) still don’t address such specific points. Sponsors and investigators are additionally expected to follow ISO 14155 on good clinical practice for clinical investigations of medical devices for human subjects (Whereas: 64).

  45. Hi. What should the Healthcare organization’s supply team (ERP-team) do to prepare for MDR and 26th of May 2020? Are there requirements for data registration linked to the different kind of Devices?

    1. Thank you for your question about identification and traceability in health institutions.

      As far as the EU MDR is concerned (Article 25), the obligation to maintain identification and traceability within the supply chain falls to the economic operators (manufacturers, importers, distributors). The EU MDR does not define the traceability requirements for the health institutions or healthcare professionals that use devices. That topic would typically be addressed in national guidelines issued by the national Competent Authorities.

  46. Can a company import a product X from a non-EU manufacturer and act at the same time as the distributor of the same product?

    1. Thank you for your question about importers and distributors.

      Yes. In the common business models the importer will most likely be the first distributor in the supply chain.

      1. Thank you very much for your reply.

        In regards to the responsabilities for importers acc. to the Article 13 “Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be
        contacted, so that their location can be established…”.
        That means, the importer’s information must be put on the label or on other document (for example: invoice) when the product arrives the EU and before delivered to the distributor(s) or end customer(s)? or the importer’s information must be already put on the product/document when exporting the product to the EU?

        As many legal manufacturers will have a grace period to bring their products into the market under MDR, does it mean that the importers and distrubutors are also covered under the grace period? or must they comply with their obligations from May 26 2020?

        1. Thank you for your question about the importers’ obligations.

          The EU MDR is concerned with the conformity of devices when the device is placed on the market (i.e. when offered for sale or supply), not with the products being imported.

          For clarification: Manufacturers of legacy MDD devices may still place those legacy devices on the market after 26 May 2020, but only on the condition they comply with the EU MDR Articles 29 and 31 on “registration”, Articles 83, 84, 85 and 86 on “post market surveillance”, and with Articles 87, 88 and 89 on “vigilance”. It is a conditional transitional provision, not an unconditional grace period.

    1. Thank you for your question about the date of application.

      The Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May.

  47. Hello eumdr,

    As per Article 2.1 – Definition of Medical device: “medical device’ means any instrument, apparatus, appliance, software, implant, reagent, MATERIAL or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes”.

    Non-woven fabric is a material which medical purposes, used to manufacture masks, protective clothing or other medical devices.

    Is Non-woven fabris a medical devices?

    Thanks.

    1. Thank you for your question about the definition of a medical device.

      Whether any item fulfils the definition of a medical device depends on the claims made by its manufacturer. If a manufacturer claims a material is suitable for a particular medical purpose, users, patients or medical condition, it may well fulfil the definition of a medical device. But if the manufacturer claims only that the material conforms to a specification, it is unlikely to fulfil the definition of a medical device.

  48. Can you have both an MDD and an MDR certificate at the same time? Or once you are issued with an MDR certificate, does the MDD certificate become invalid?

    1. Thank you for your question about certificates.

      The manufacturer decides whether and when a specific device complies with the MDD or the MDR and maintains the Declaration of Conformity for the specific device to reflect this. Any notified body certificates must be consistent with the legislation and conformity assessment route claimed by the manufacturer on the Declaration of Conformity.

  49. In regards to 23.2 Label requirements.
    As defined earlier in Chapter 1 Article 2 (13) ‘label’ means the written, printed or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices;
    Are these then seen as separate and individual “labels” – i.e. device label(s), packaging label(s), etc. or as holistically as a single ‘label’?
    If seen as individual items, then I would assume each ‘label’ should contain as much content as required to meet the Regulations set forth in 23.2?
    Is there any good examples of device, package and packaging labels available as guidance?

    1. Thank you for your question about labels.

      As stated in the definition it is either one or the other. There is no EU specific guidance on the topic of labelling. There is however guidance from IMDRF/GRRP WG/N52. If your company is a member of an industry association there may also be a sector specific position or consensus.

  50. Hi our notified body told us the EU MDR extension required further approval before it was official. When I mentioned that the extension was published on the OJ on 24 April they said it would be End of May before everything would be officially approved. This was not my understanding of it. So my question is we only have MDD certified products, if we haven’t implemented our procedure changes within our QMS such as pms procedure vigilance procedure can they give us nonconformities to the MDR in audits such as MDSAP audits or ISO and Tech file audits. We are not transitioning ourCurrent MDD certified Products to MDR so will take these off the market once our EC cert expires or in the event of a significant change.

    1. Thank you for your question about the postponement of the date of application

      As written in the amending Regulation 2020/561, the Regulation enters into force on the day of its publication in the Official Journal of the European Union. The date of publication was 24 April. The date of application of the Medical Devices Regulation has now postponed until May 2021.

  51. Due to the extension of the MDR for one year, labels IFU’s etc have already been completed for Class I devices’s, although the DoC has not been completed and signed to the MDR is it illegal to have the MD symbol on the labels with explanation in the IFU DoC signed off under the MDD.

    1. Thank you for your question about labelling.

      The delay to the date of application does not remove the possibility to comply with the EU MDR earlier than the date of application. If your company’s Class I device is EU MDR compliant now, it can be registered now with your Competent Authority and it can be placed on the market now as an EU MDR compliant device. If your company intends to continue marketing its Class I device as an MDD compliant device and add additional information or symbols, that is also possible. As long as the device complies with the (minimum) labelling requirements in Section 13 of Annex I of the MDD.

    1. Thank you for your question about clinical investigations involving CE marked devices

      Such investigations are regulated by Article 74.
      If a clinical investigation is planned to further assess a device which is already CE marked and is within the scope of its intended purpose, it is referred to as PMCF (Post Market Clinical Follow-up) investigation. For example, for implantable devices and class III devices. However, if a PMCF investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use, and those additional procedures are invasive or burdensome, the sponsor must notify the Member States concerned at least 30 days prior to its commencement via the electronic system referred to in Article 73.
      Alternatively, if a clinical investigation to further assess a device which is already CE marked would be outside the scope of its intended purpose, the sponsor must follow Articles 62 to 81.

    1. Thank you for your question about economic operators.

      It is not prohibited and each role has their own specific obligations.

  52. I have a question regarding the importer symbol… if our importer does not carry out any tasks written in Article 16(1) and (2), does that mean we do not need to use the importer symbol per Article 16(3)?

    1. Thank you for your question about the importer’s requirements

      The obligation in Article 13(3) for an importer to identify themselves, applies to all importers regardless of whether they perform the activities described in Article 16(2) or not.

  53. Hello,
    Does the name & Address of Importer need to be written on product labeling? Art. 13 paragraph 3 of MDR states that an importer shall indicate their name and address on labelling. However, this requirement is not mentioned under Annex I chapter III (GSPR).

    1. Thank you for your question about the name and address of the importer.

      These are different obligations which are addressed to different economic operators. Annex I is an obligation of the manufacturer. EU manufacturers will have no importer. Whereas Article 13 is an obligation of importers. Devices coming from non-EU manufacturers may have more than one importer.

      1. Hello,
        I have additional questions, regarding your comments “Devices coming from non-EU manufacturers may have more than one importer”.

        We are non-EU manufacturer and we have distributors in each countries in Europe.
        In this case, should we have importers in each EU countries, which means that current each distributors become importers? Or should we have one importer who covers whole EU countries, which means that we decide one distributor to become an importer?

        1. Thank you for your question about importers.

          Your question suggests that you already use several EU importers today. Possibly you only consider them to be distributors, but they are importers, already today. The EU MDR does not change their status as importers. What changes on 26 May 2021 is that those existing importers will have additional obligations under the EU MDR (Article 13). Obligations which they didn’t have under the MDD. But as to whether you should change your distribution model because of the new obligations on your importers, that is a business question not a regulation question.

          1. Thank you for your reply.
            Does “change your distribution model” in your answer mean that for example, ‘we choose one importer and make the others as distributors’?
            In fact, this suggestion was from one European RA agency.
            According to them, we better appoint one importer and make this one importer do the duties under MDR, especially EUDAMED data entry. They also said that having close communication with one importer avoids confusion than several importers in Europe.

            Moreover, from what you answered previously, I guess that importer does not need to provide the goods but just verify the conformity (documentation and data entries) of the goods.
            Considering this, each distributors can be provided with the goods from manufacturer not through importer.

            Thank you for your answers in advance.

          2. Thank you for your follow up question.

            The obligations of importers are not exclusive to medical devices and they are not new. They have been in place since 2008. Article 11 of the EU MDR is restating Article R4 of DECISION No 768/2008/EC, a common framework for the marketing of products. Article 11 provides the medical device importer with additional details which must be included in his conformity verification. For example, verifying that the manufacturer has assigned a UDI.
            A manufacturer does not appoint an importer like he does an authorised representative, as the ‘Blue Guide’ confirms: “The importer needs neither a mandate from the manufacturer, nor a preferential relationship with the manufacturer like the authorised representative.” You can read more about the roles and responsibilities of importers in the ‘Blue Guide’ on the implementation of EU products rules (2016/C 272/01).

          3. Hi,
            We are a Non-EU manufacturer and have 14 distributors in Europe, all of which are also importers of our product. We use standard product labelling for all our EU countries where we sell. With the new labelling regulation, does this mean that we have to add 14 importer names onto our labelling? Or, alternatively create separate labelling for each of the EU countries that we sell in?

          4. Thank you for your question about importers.

            Please see the earlier reply to Lee. The obligation of importers to indicate their name and contact address on the packaging, or in an accompanying document, is not new. Article 11 of the EU MDR is restating rules which have existed since 2008.
            As manufacturer, you can, if you wish, add your importer’s name and address to your labelling, but it is not your obligation.

  54. The MDR article 61, (4), (a) describes

    4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
    (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;

    Does this mean,
    (1) a clinical investigation shall be conducted within the Member States?;
    (2) a clinical investigation planned to be conducted in a country other the Member States shall be authorized by relevant competent authority of the Member State somehow?; or
    (3) is this requirement only applicable when the clinical investigation is to be conducted within the Member States? If so, would you please give me a reference?

    1. Thank you for your question about clinical investigation authorisations.

      You are referring to Article 62.
      It means, a sponsor wishes to conduct a clinical investigation in a member state (EU country), must obtain authorisation (permission) from that member state. More specifically, from the relevant competent authority in that member state.
      The requirement is the same for every EU member state. That means, a clinical investigation to be conducted in all twenty-seven EU member states would require authorisations in all twenty-seven EU member states.
      The EU MDR is only applicable in the 27 member states of the European union and some other European states who have treaties with the EU. Questions about the scope of EU law should be addressed to an appropriately qualified lawyer.

  55. We are developing a software that integrates with a smart watch to read heart rate, body temperature, and SPO2 (non-invasive). The smart watch has CE marking.
    1. Will the Application be termed as SaMD ?
    2. In that case, will it be Class I ?
    3. Is the DOA 26 May 2021 for this Application also ?

    Thanks in advance for your clarifications.

    1. Thank you for your question about software.

      Please note: The term “software as a medical device” (SaMD) is not used in Europe.

      1. MDCG guidance document 2019-11 is intended to help manufacturers such as yourselves, decide if their software is a medical device or not.
      2. MDCG guidance document 2019-11 should also help you to classify your device, if you decide that your software is a medical device.
      3. Today, manufacturers can still choose if they want to place their devices, including software devices, on the EU market according to the MDD or the EU MDR. The date of application is only relevant to manufacturers who are currently still placing devices on the EU market according to the MDD, because that possibility will be very limited after the date of application of the EU MDR.

  56. A Medical Device is manufactured and sold under MDD with one notified body number (engraved on the product). After transition from MDD to MDR the same medical device will be manufactured and sold under MDR with a different notified body number. In case of repair of one product sold before the transitioning (i.e. MDD compliant), where the component to be changed has the CE mark with notified body number engraved on it, would we then need replace the component with one that has the MDD notified body number engraved? Or we can produce and replace the component with one that has the MDR notified body number engraved? If we use the component which has the MDR notified body number engraved as replacement, would we then need to supply the user with a new MDR compliant IFU additionally?

    1. Thank you for your question about repairs and notified body numbers.

      This question relates to the concept of placing on the market. Placing on the market applies to individual devices, not product groups or types. The individual devices that were placed on the market according to the MDD, will remain MDD devices until the end of their life, even if they are repaired. Their original EC Declaration of Conformity and NB certificates do not change retrospectively and they are not placed on the market again, even if they are repaired. That only happens if they are “fully refurbished”.

  57. I have a question regarding ‘place one the market’. You answered to Terese on Dec. 9th, 2019 that “The condition, according to Article 120 (4), is that they are placed on the market prior to 26 May 2020. Meaning, ownership of the devices is transferred from the manufacturer or importer to a distributor within Europe.”.
    On other hand, “2.4 Placing o the market (P.19)” of ‘Blue law’ says “Placing on the market is considered NOT to take place where a product is : – in stocks of the manufacture or the importer , where the product is not yet available, that is, when it is not supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonization legislation.”
    It looks that a device is placed on the market when not only transferring ownership the device from a manufacture to a importer but also shipping the device from importer warehouse to a dealer or a customer physically.
    Do we as an importer need a device to ship to a dealer or a customer in order to place on the market?

    1. Thank you for your question about placing on the market.

      This is correct. The legal transfer of ownership would normally be associated with a physical transfer. Although whether the physical transfer takes place before or after the legal transfer, would be a matter for the parties involved. But a physical transfer of goods without transferring the ownership, would not constitute placing on the market. In case of further questions, you are recommended to consult a suitably qualified EU lawyer.

  58. We understand that a manufacture have to accompany information, which includes an IFU, in official language according to Article 10(11) . I know some countries accept English in stead of their official languages, especially for a professional use. Also, some consistories are still under consideration.
    Does the EU committee publish the latest information which shows the counties accept other language(s) than their official language? I’d appreciate it if you could have those information and share with us. It is help us.

    Thank you for your corporation.

    Best Regards,

    1. Thank you for your question about languages used to provide information.

      Language requirements are decided by the Member States. However, fulfilling the language requirements is an obligation of both the manufacturer and distributor. As the EU MDR says; in Article 10 (11) “Manufacturers shall ensure that the device is accompanied by the information… in an official Union language(s) determined by the Member State in which the device is made available…”, and in Article 14 (2b) (distributors shall verify that) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10 (11). The best way to confirm the national language requirements is therefore likely to be via your distributor(s).

  59. If we are processing medical devices only within our own Hospital Trust is MDR a requirement? Or does it only become a requirement when you are processing on behalf of a 3rd party?

    1. Thank you for your question about re-processing of single use devices.

      According to Article 17 (1), reprocessing of single use devices may only take place if permitted by national law. Further, Article 17 (3) allows Member States to decide whether different rules can apply if single-use devices are reprocessed and reused within a health institution. In short, this is very much a matter for the national Competent Authorities.

      As far as the UK is concerned, the current position of MHRA can be found at the link below:

      https://www.gov.uk/government/publications/single-use-medical-devices-implications-and-consequences-of-re-use

      1. Just to clarify we are not reprocessing single use devices, they are instrument trays that are sterilised between operations, which we are processing for our own hospital Trust.

        1. The EU MDR does not regulate the operation you are performing. The only reprocessing requirements contained in the EU MDR are those for reprocessing single use devices. More generally, the EU MDR regulates the activities of economic operators such as manufacturers, importers and distributors of medical devices, but not the activities of users.

  60. Can devices, that are being put to market for the first time in the EU today, do so according to the MDD until May 2021? Or do all new devices have to be put to market according to the MDR?

    1. Thank you for your question about the amended date of application.

      Yes, devices can still be placed on the market according to the MDD until 26 May 2020. Regulation (EU) 2020/561 of 23 April 2020 amended the date of application of the EU MDR to 26 May 2021.

  61. Hi,
    does all medical devices manufactuers outside EU will be required to have a authorised representitives? Or is it just regarding the classification I to have an authorised representitives? Mine product will be classifeid as Class IIa and based outside the EU, do I need an EU authorised representitives as well?
    Appreaciated for your reply!

    1. Thank you for your question about Authorised Representatives

      Yes, a manufacturer that is not a registered company of an EU Member State or an EEA county must appoint an authorised representative. It is not related to the class of the device. It is determined by the location of the manufacturer.

  62. Device label with existing (old) NB address VS Device label with new NB address:
    I have a situation where the notified body is updated due to Brexit while the device label still carry the old NB details. I have two questions: Number 01: For how long I can continue placing the product in the market with the existing (old) NB address on the label? and question number 02: If I make to amend the labels can this be a soft switch (continue selling and exhausting all existing labels, while simultaneously placing/replacing with the new labels) OR I must do a hard switch?

    1. Thank you for your question about the notified body number

      It has never been a requirement to have the address of the notified body on labels. Not in the MDD nor in the EU MDR.

      Article 58 of the EU MDR addresses the topic of changing notified body. Article 58 says the manufacturer must have an agreement with the (new) incoming notified body. It also says that agreement must include “(b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer…” It is a matter to be discussed with your notified body. There is no time limit in the EU MDR.

  63. We are a UK-based Legal Manufacturer, certified by an EU-based Notified Body (legacy MDD), selling product in the EU. However, physical device manufacture takes place within the EU. Post Brexit, we will not have an importer (there is no product crossing a border), and in some EU countries we do not have a distributor (we manage sales directly via an EU-based warehouse). We have appointed an EU Authorised Representative. Can we continue to place product onto the market in the EU in the event of a no-deal brexit, or must this be undertaken by an EU-based person (probably the EC REP in our case)?

    1. Thank you for your question about the end of the Brexit transition.

      You are recommended to consult a suitably qualified lawyer who is familiar with your business model. But it may be more appropriate to consider how the ownership of the product is moving across borders, i.e. invoices between legal entities in different countries, not only the movement of the physical product.
      The EU commission has published a Stakeholder notice on industrial products which also applies to medical devices. When the transition period ends on 31 December 2020, a UK manufacturer will no longer be considered an economic operator according to Union legislation. The consequence is that a UK manufacture can no longer place products on the EU market. It means your current distributer (the physical device manufacturer) will become your importer and inherit the importers obligations.

  64. Love this page! Thanks for answering wide range of questions. Can sales teams place bids with EU companies with products prior to their approval? Bids are often for sales > 1 year in the future and include software/devices still in development. My understanding was the MDD allowed this as long as the CE mark was approved prior to shipping into EU. Is this accurate and will it change under the EU MDR?

    1. Thank you for your feedback and for your question about commercial practices.

      The MDD did not say anything about this topic and neither does the EU MDR. Nevertheless, given that the Article 1 (1) of the EU MDR says “This Regulation lays down rules concerning the placing (devices) on the market…”, you may wish to consult the ‘Blue Guide’ on EU products rules (ref. 2016/C 272/01). The Blue guide says “An offer or agreement concluded before the stage of manufacture has been finalised cannot be considered as placing on the market..”

  65. Hello,

    Are Software companies required to translated their User Interface if they are classified as class III? I under stand that the IFUs, labels must be but these requirement do not seem to be clearly outlined.

    1. Thank you for your question about translations.

      You are correct that obligation of Article 11(11) / Chapter III of Annex I concerns labels and instructions. However, your question really falls within the scope of the general requirements of Chapter I of Annex I.
      Devices must be suitable for their intended purpose during normal conditions of use, Annex I(1). As manufacturer you define normal use, which it seems from your question may include users with different languages. You also have to control risks, Annex I(4), which might necessitate training users, and to eliminate or reduce risks related to use error, Annex I(5). So, while the EU MDR doesn’t address such specific topics as the languages needed for user interfaces, it does obligate manufacturers to consider these types of questions in the course of their risk management activities.

  66. Thank you for the insightful information.

    We have a legacy device with CE marking under MDD, and are planning to convert it to MDR by May 2024 when the certification becomes void.

    My questions are:
    1. As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial?

    2. What type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR? Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices.

    3. Do we need to submit clinical trial data if MDR requires clinical trial?

    Thank you in advance.

    1. Thank you for your question about clinical evidence requirements for legacy devices.

      You are recommended to consult MDCG 2020-6 “Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC”, as this guidance was developed specifically to assist manufacturers and notified bodies with these questions.
      In short; a clinical investigation is not an automatic requirement, even for Class III devices. Article 61 contains several exemptions. However, Article 61 also says it is for you as the manufacturer to “specify and justify the level of clinical evidence necessary…”. But if you and your notified body have been following the guidance of MEDDEV 2.7/1 rev. 4, your clinical evaluation is likely already close to the standard required by the EU MDR.

  67. We are a sterile Services department sterilising instrument trays between uses. Can you explain a little about the Eudamed unique Identification. Does this apply to every instrument on the tray or the whole tray? If I use scissors as an example- do I have to register every pair of scissors. Would it be our responsibility to do this or the manufacturers of the scissors? I understand that we take multiple instruments to form a tray used in a specific procedure and therefore are ‘device manufacturers’ so I assume we would just register the tray?

    If we are only supplying devices within our own Trust and not providing a 3rd party service do we need to have MDR? Is it still considered ‘putting on the market’ if only supplying internally?

    1. Thank you for your question about UDI and EUDAMED

      Concerning UDI, the manufacturer assigns the UDI to the device (See Article 29). Concerning EUDAMED, the manufacturer registers in EUDAMED together with, for non-EU based manufacturers, the authorised representative and importer (See Article 31).

    1. Thank you for your question about the obligation in Article 10(11), to ensure the device is accompanied by information in the official language(s) of the Member State in which the device is made available.

      It is a case by case decision by the manufacturer. Probably the manufacturer’s name and address cannot be translated. But the device name, if it is used to identify the device, the contents of the packaging or the intended purpose, then it would be necessary.
      The general requirement of Annex I Section 23(1) is that each device is accompanied by the information needed to identify the device, its manufacturer, and any safety and performance information relevant to the user. In case of uncertainty, this question should be tested in the risk management activities.

  68. If a Notified Body (NB) has officially withdrawn from European MDR designation and no longer holds valid EU MDD designation, will the EC Certificates and ISO 13485:2016 certificates issued by the NB still be considered valid, if they have no expired? If so, what is the basis for validity if the NB no longer exists?

    1. Thank you for your question about former notified bodies.

      Although devices already placed on the market, i.e. already in the distribution chain, will be unaffected. For devices not yet placed on the market, i.e. newly manufactured, a new notified body and new certificates will be required. It is a question for your new notified body what recognition they will give to the certificates of your previous notified body.

  69. Can you please provide guidance on this scenario:
    We have a platform that has been marketed for 14 years and has a long clinical history including a US FDA PMA clinical study and numerous publications re use in the US and EU. The formal PMA study only captured performance of certain codes, but all product codes share the same basic science, same software, same hardware, and the same performance measures. All codes have bench and animal data supporting consistency of performance. Assuming the data for those codes studied under the PMA is valid to support EU MDR submission, and the bench & chronic animal data exists for all codes, would additional clinical studies be required for each code to be registered in the EU?

    1. Thank you for your question about clinical data.

      The two regulatory systems are different. In Europe your question is more a clinical question than a regulatory question. In Europe the manufacturer defines “the device” within the meaning of the regulation. As long as the different variants share the same intended purpose, same intended target groups, same intended clinical benefits and clinical outcomes etc., it may be legitimate to consider them as one and the same device. i.e. they will share the same technical documentation, clinical evaluation, notified body certificate etc.
      Defining “the device” and the variants of that device which are to be available on the EU market is an important early step. It can influence not only the scope of your pre and post market clinical activities, but also the approaches related to UDI assignment, scope of technical documentation, the declaration of conformity and the registration.

  70. When a device is discontinued from Market, but still few units are in Market. What are the liabilities that imply? How to maintain compliance? Will MDR Transition still imply?

    1. Thank you for your question about discontinued devices.

      If a device is no longer on the market but is still in use, e.g. an implant, the vigilance obligations still apply. If the device was placed on the market according to the MDD then MEDDEV 2.12-1 rev. 8, 2013 together with the additional guidance issued in July 2019, still applies.

    1. Thank you for your question about notified body certificates.

      Please keep in mind that the requirements of the MDD or EU MDR apply to individual devices, not to types of devices. Every individual device (i.e. batch number or serial number specific) has a corresponding declaration of conformity. That declaration of conformity shows which regulatory requirements the device conforms to, e.g. a Directive or the Regulation and notified body certificate number etc. So, while an individual device cannot have two certificates, a manufacturer can hold several valid certificates concurrently.

  71. Hello,

    Regarding EU declaration of conformity ANNEX IV is it obligatory to list all the applicable harmonised standards to which the products comply or is it enough to include this reference ” all supporting documentation – including the list of applicable standards – is retained at the premises of the manufacturer and can be provided upon request”?
    Thank you for your answer!

    1. Thank you for your question about the EU declaration of conformity.

      The requirements listed in Annex IV are the minimum requirements of the EU declaration of conformity. A manufacturer is free to add other items, but the items listed in Annex IV are currently all that are required by the EU MDR. However, if you do intend to depart from Annex IV; because a draft of the EU declaration of conformity has to be submitted to the notified body, you might consider checking first that your planned format is also acceptable to your notified body.

  72. If we want to keep the original manufacturer as a legal manufacturer (on labels) but we want our brand on the product – what are the responsibilities of us? Are we considered as well as a manufacturer and needs to be in the possesion of technical documentation?
    Regarding Article 16 of the obligations of manufacturer for the company that is not mentioned as the manufacturer on the label but put their device name on the product – is it considered as a manufacturer as well and needs to be in possesion of TD?

    1. Thank you for your question about the manufacturer.

      There is only ever one manufacturer within the meaning of the regulation. The manufacturer is the person that fulfils the general obligations in Article 10 and all the other obligations addressed to the manufacturer, including putting their name and address on the device and in the instructions; is registered in EUDAMED as the manufacturer etc.
      According to Article 16 1.(a), as long as you enter into an agreement with the manufacturer, whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in the Regulation. You can make available on the market a device under your name, registered trade name or registered trade mark, without assuming the obligations incumbent on manufacturers.

  73. I have a question regarding device classification:
    A medical surgical invasive device (drill/knive/pin) is delivered to the hospital non-sterile. The device is available in a number of types/configurations, depending on the patient, one type is used. The type which is used is selected during the surgery, however multiple types are available sterile in the sterilisation tray during the surgery (however not used/in contact with the patient). The type device used on the patient shall be discarded (disposed). All other types, not used on the patient, will be resterilized again for the next surgery.
    Is the device a single-use device? Because it is used on one patient? (thus class IIa)
    Or is the device reusable, because most items are reprocessed multiple times before being used on the patient? (thus class Ir)

    Thanks for your response!

    1. Thank you for your question about classification.

      The intended use and classification are not dependent on the activities of the user. The manufacturer has to decide the intended use and to specify the intended use in the instructions and in the technical documentation etc. In case several classification rules can be applied, as stated in Annex VIII 3.5, “the strictest rule and sub-rule resulting in the higher classification shall apply.”

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