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.
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.
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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