Will the new European rules on medical devices and in vitro medical devices, currently being transposed in the Member States, be sufficient to avoid a new Implant files scandal? Two conflicting opinions were opposed in the European Parliament's Environment Committee on Wednesday 27 February.
The question of the transparency of the future Eudamed database was at the heart of the discussions (see EUROPE 12146). The International Consortium of Investigative Journalists (ICIJ), which presented the results of its investigation to MEPs, suggested that the Commission did not intend to make public incident reports related to these devices or pre-approval data. According to Simon Bowers, the institution is concerned that this may frighten the general public and discourage industry from raising concerns. The journalist described these explanations as "shocking".
The European Commission and industry reacted immediately to these statements. The Commission representative indicated that the modalities of the Eudamed database were still under discussion: "We are still discussing with Member States the type of data to be made public and it is indeed possible that not everything will be made public. A good analysis is necessary to see if the incidents are related to the devices or to misuse or the clinical environment. It is in our interest to publish accurate and verified information, rather than misleading automatic reports.". For his part, the MedTech Europe representative, fearing with difficulty that the new rules would be revised before they were even implemented, indicating that the industry was fully prepared to cooperate.
Arguments that did not seem to convince the few MEPs to speak, with the exception of Françoise Grossetête (EPP, France) who once again defended the new rules. MEPs Michèle Rivasi (Greens/EFA, France), Annie Schreijer-Pierik (EPP, the Netherlands) and Nicola Caputo (S&D, Italy) all lamented that the new regulations did not go further in terms of transparency; Michèle Rivasi and Nicola Caputo also lamented the absence of a centralised agency, such as the one for medicines.
It should be recalled that the Medical Devices Regulation (2017/745) is to apply starting on 26 May 2020 and the in vitro Medical Devices Regulation (2017/746) on 26 May 2022.
Brexit: nothing changes
As in October last year, MEPs expressed concern about delays in the designation of notified bodies (responsible for assessing the conformity of a device) in accordance with the new rules. They also expressed concerns about the impact of Brexit on the sector.
And just as in October, the Commission was reassuring. On the first question, it stated that 45 applications had been submitted, 25 evaluations were ongoing and 3 were about to start. It added, with some language precautions, that she expected these 45 requests to be successful. As for Brexit, it argued that it was not necessary at this stage to consider emergency measures in the event of a no deal, as is currently the case for other sectors. It should be recalled that at the time, the Commissioner Bieńkowska stated that 4 companies currently responsible for conformity assessment in the United Kingdom had taken steps to prepare for Brexit. (Original version in French by Sophie Petitjean)