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

Use the Contact form to submit your question.


 

26 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.

  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.

  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.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.