Implementation of Regulation (EU) 2017/745 on medical devices
22.4.2022
Question for oral answer O-000014/2022
to the Commission
Rule 136
Nathalie Colin-Oesterlé (PPE), Anne Sander (PPE), Liudas Mažylis (PPE), Geoffroy Didier (PPE), Marion Walsmann (PPE), François-Xavier Bellamy (PPE), Brice Hortefeux (PPE), Edina Tóth (NI), Sara Skyttedal (PPE), Dolors Montserrat (PPE), Dominique Riquet (Renew), Agnès Evren (PPE), Arnaud Danjean (PPE), Ladislav Ilčić (ECR), Romana Tomc (PPE), Angelika Niebler (PPE), Nadine Morano (PPE), Lars Patrick Berg (ECR), Stéphanie Yon-Courtin (Renew), Joanna Kopcińska (ECR), Franc Bogovič (PPE), Bartosz Arłukowicz (PPE), Tomas Tobé (PPE), Salvatore De Meo (PPE), Ivan Vilibor Sinčić (NI), Seán Kelly (PPE), Susana Solís Pérez (Renew), Norbert Lins (PPE), Andreas Schwab (PPE), Marian-Jean Marinescu (PPE), Pietro Fiocchi (ECR), Angelika Winzig (PPE), Axel Voss (PPE), Danuta Maria Hübner (PPE), Robert Biedroń (S&D), María Soraya Rodríguez Ramos (Renew), Pernille Weiss (PPE)
Regulation (EU) 2017/745 on medical devices, which started to apply on 26 May 2021, risks severely penalising the European medical technology industry, thus negatively affecting fair access to care for all European citizens, the competitiveness of European businesses, and employment on our continent.
In accordance with this regulation, all medical devices produced in Europe must be re-certified by 26 May 2024. However, European medical device manufacturers claim that it is impossible to have almost 20 000 technologies certified in such a short time. There are two reasons for this: the COVID crisis on the one hand, and the lack of notified bodies on the other.
The only way to streamline the process is to adopt transitional provisions on medical devices, allowing the deferred application of the requirements.
In other words, this means extending the transitional provisions laid down in Regulation (EU) 2017/745 beyond May 2024 for medical devices placed on the market before May 2021. A similar extension was granted for in vitro medical devices regulated by Regulation (EU) 2017/746 following a Commission proposal of 14 October 2021. There is therefore no reason why this should not be the case for other types of devices.
In this way, new medical devices placed on the market after May 2021 will benefit directly from the new certification, allowing them to be placed on the market quickly, while older medical devices will benefit from legal certainty.
If the deadline is not extended, the delayed certification of medical devices produced in Europe threatens to undermine three of the main objectives of the Health Europe project, namely:
– Continuity of supply of medical devices needed for patient care and restoration, which would lead to serious risks of shortages;
– The competitiveness of European industry, which is prohibited from selling its products, some of which are being placed on the market today;
– The relocation of the strategic pharmaceutical industry, which cannot be achieved if investors are guaranteed regulatory stability in China but not in Europe.
In light of the above, does the Commission intend to propose extending the transitional provisions of Regulation (EU) 2017/745 for medical devices placed on the market before May 2021, given that not doing so would lead to a disruption of supply within the European Union?
Submitted: 22.4.2022
Lapses: 23.7.2022