At the plenary session of the European Parliament on 24 November, European Commissioner for Health and Food Safety, Stella Kyriakides, indicated that the European Commission is considering a number of measures to address the recertification crisis plaguing the EU’s new medical device regulatory framework (EU MDR) – including the possibility of legislative intervention.[1]

The recertification crisis has arisen from two main factors: the relatively short duration of the transitional period under the EU MDR, within which all existing medical devices on the European market must undergo recertification or come off the market, and a lack of Notified Bodies to conduct the large number of recertifications which are needed.

This crisis is not new. Senior figures in the European medtech and pharma industries have been calling for action for a very long time, warning that it would be catastrophic for patient care if a significant proportion of medical devices were forced off the market at the end of the transitional period due to a lack of regulatory infrastructure.[2] [3] The French and German industry bodies for medical technology went so far as to warn of a “collapse in patient care” if urgent steps were not taken.[4]

The conclusion of the EU MDR transitional period on 26 May 2024 is rapidly approaching and tension regarding what action to take is clearly rising in the European institutions. A number of MEPs speaking at the plenary session had some quite angry words to say regarding the situation which has been allowed to develop.

In response to MEPs, Kyriakides informed the Parliament that the European Commission is considering all its options to deal with the crisis and that she intends to present a package of proposed measures to the meeting of EU health ministers (EPSCO) on 9 December.[5]. Most interestingly, she openly stated that legislative measures to amend the EU MDR before the end of the transitional period are being considered. Many figures in industry have been calling for legislative measures for some time, and we had heard that some ministers in EU Member States had started to take up that call as well, but we had understood that the European Commission was reticent to reopen the text of the EU MDR. It now seems that the European Commission is feeling such pressure from industry and political figures that it can no longer rule anything out.

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[1] Regulation (EU) 2017/745 on medical devices
[2] https://www.bristows.com/news/pharma-industry-joins-calls-for-delay-to-ivdr-application-date/
[3] https://www.bristows.com/news/more-mdr-notified-bodies-ivdr-lags-behind-but-is-help-on-the-way/
[4] https://www.bristows.com/news/a-franco-german-clarion-call-to-ease-the-burden-of-the-mdr-and-ivdr/
[5] https://multimedia.europarl.europa.eu/en/webstreaming/plenary-session_20221124-0900-PLENARY, starting at 15:06