This post is an update to our recent blog post where Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shared her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline. You can read that post here.

Friday, April 17, 2020 - UPDATE - Today the European Parliament voted on, and approved, the European Commission’s proposal (2020/0060 (COD)) to amend Regulation (EU) 2017/745 to extend the European Union's Medical Device Regulation (MDR) date of applicability by one year to 26-May-2021. The proposal came after the immense impact of the COVID-19 pandemic has been felt by medical device manufacturers globally.

 

C9-0098/2020
– am 1

C9-0098/2020
– am 2

C9-0098/2020
– am 3

C9-0098/2020
– am 4S

Votes Cast:

691

691

691

691

Votes in Favor:

685

685

685

686

Votes Against:

3

4

4

2

Abstentions:

3

2

2

3

Source of Vote Results: European Parliament. Accessed 17-April-2020. https://www.europarl.europa.eu/sed/doc/news/flash/23702/results%201th%20slot%20-%20votes%20on%20amendments_en.pdf

The approval by Parliament, and subsequent approval by European Union (EU) Council expected at the end of this month, will officially move the Date of Applicability of the EU MDR regulation from 26-May-2020 to 26-May-2021. The delay will allow manufacturers to continue utilizing the currently used Medical Device Directive (MDD) to place medical device products on the market with CE Markings until next year.

This includes new products or changes that you may have been planning for EU MDR that fall within this time window. To make sure that you plan accordingly, it is recommended that you consult with your Notified Body (NB) on how long they will continue to accept MDD applications as we get closer to the EU MDR applicability date in 2021.

Most NBs had cut off MDD submissions/renewals in 2019 and we expect they will be reluctant to resume MDD reviews as it impacts their Quality Systems. The changes voted on today incorporate the November 2019 corrigendum which allows Class I reusable (Ir) devices on a Declaration of Conformity by 26-May-2021 to remain on the market until 25-May-2024.

Although this may be a welcome relief and expected decision by Parliament given the COVID-19 pandemic, it is important to remember that most aspects of the EU MDR remain unchanged by this amendment. First, it should be noted that this does not change the last date of expiry for MDD issued certificates (26-May-2024). Any new certificates issued under MDD by your NB will not go past this expiry date and no medical device products can be made after this date under MDD.

Second, the last date to sell medical devices that were placed on the market before expiry (ex. warehouse inventory) is still 26-May-2025 and has not changed.

Third, the previous dates for Unique Device Identifier (UDI) and direct part marking also remain unchanged and it is important to remember that this amendment does not impact or extend the In-Vitro Diagnostic Regulation (IVDR) which remains unchanged and is still applicable as of 26-May-2022.

As the mindset of the NBs have already started to transition to EU MDR requirements, R&Q has begun to see audit findings and review questions reflective of the new regulation. This is especially true concerning Clinical Evaluation Reports (CERs), Post Market Surveillance (PMS), and Vigilance reporting.

EU MDR is the inevitable future and although it is slightly delayed for now, it is still where the industry is headed and the more time dedicated to planning now the better prepared and positioned your organization will be for success.

Have questions? Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know.


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R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blogview our service offerings, watch free webinars, and more at RQTeam.com.

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