The European Commission rejects any particular delays or difficulties in the implementation of the new rules on medical devices and in vitro medical devices adopted in 2017. However, in a question on Thursday 25 October in plenary session, MEPs fear that the deadlines will not be respected and that the competent notified bodies will be missing.
However, the co-legislators had provided for a transitional period to allow the market to prepare itself: the regulation on medical devices (2017/745) is to apply on 26 May 2020 and the regulation on in vitro medical devices (2017/746) on 26 May 2022. However, with one year and seven months to go before the first deadline, the system seems far from being in place, say MEPs from all sides. Their main fear concerns the re-designation of notified bodies, i.e. those bodies responsible for ensuring the conformity of a device. "By May 2018, of the 59 existing notified bodies, only 20 to 30 had requested a new designation, and the joint assessment of the process of designation of notified bodies takes about 18 months", the written question states, suggesting that leaving the United Kingdom from the EU could further worsen the situation. For Michèle Rivasi (Greens/EFA, France), it is clear that a new health scandal (such as that of hip replacements in 2015) is hanging over Europe.
"Some people say I'm too optimistic. But in fact, I am realistic and confident: we are following the situation closely and, for the moment, we are in the dark and are meeting deadlines," said the Commissioner for the Internal Market and Industry, Elżbieta Bieńkowska. It states that the first notified body designated under the new rules could be established "before the end of this year". It also states that the 4 companies currently responsible for conformity assessment in the United Kingdom have taken steps to prepare for Brexit. (Original version in French by Sophie Petitjean)