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, 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


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.

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12 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.

    The EU Commission first has to designate an “issuing entity”, for example but this has not happened yet.
    Once the designated issuing entities are known, Manufacturers can apply for the Basic UDI-DI, which can then be uploaded to EUDAMED, put on the EU Declaration of Conformity, put on the Notified Body certificate etc. See EU MDR Article 27, 2. and 3.

  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.

      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. The general interpretation of Article 123 is that once EUDAMED goes live, economic operators will have six months to register in EUDAMED and upload their data.

    1. Thank you for your question. 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. 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.

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