The European Commission is approaching with some confidence the new leaks revealed by the International Consortium of Investigative Journalists on the shortcomings of the medical device certification system, recalling that new European rules would enter into force by 2022 at the latest.
"This reform responded to the problem of PIP breast implants, which showed regulatory problems [...] It aims to ensure the highest quality, safety and reliability of medical devices", the institution commented on Monday, November 26.
The day before, several European newspapers had revealed the existence of thousands of incidents related to implants. In particular, the installation of an implant is to have injured more than 1.7 million people in 10 years and caused the death of 83,000 people, without these problems being recorded in a register.
New European rules applicable from 2020
It is unclear whether the new European rules will really change the situation: the regulation (2017/745) on medical devices will only enter into force in 2020 and the regulation (2017/746) on in vitro medical devices in 2022.
In theory, the texts provide for a two-tiered registration system: - the creation at European level of a database called Eudamed in which manufacturers will have to enter incident reports; - at national level, the obligation for the competent authorities to facilitate and record, in a centralised manner, the reports they receive from health professionals, users and patients.
The Eudamed database, which will be available from 2020, will provide detailed information on the devices on the market, including serious incident reports, safety corrective actions, safety advisories, periodic summary reports on serious cases and trend reports on non-serious incidents.
In addition, a new identification system, based on a unique device identifier (UDI), will also allow better tracking and traceability of devices on the market.
Some of these issues are covered by secondary legislation (implementing and/or delegated acts).
Scrutiny in the European Parliament
In the European Parliament, the S&D group reacted by advocating for the rapid implementation of the new rules, knowing that the whole European Parliament had already expressed itself in the same way recently (see EUROPE 12125). The Greens/EFA Group, for its part, called for a debate in plenary session on this scandal. (Original version in French by Sophie Petitjean)