Member States' health authorities are actively preparing for this: in less than a year, the regulation on medical devices (Regulation 2017/745) will become applicable and, in three years, the regulation on in vitro medical devices (Regulation 2017/746) will become applicable. However, many questions remain outstanding, in particular with regard to notified bodies and the transparency of the future Eudamed database.
The medical devices are products for internal and external use, such as contact lenses, pregnancy tests, pacemakers, breast implants, hip prostheses and HIV blood tests.
In 2017, the EU adopted new rules to strengthen the safety of medical devices by tightening controls, including those on controllers (notified bodies). It also provides for a new risk classification system.
At the last Health Council on 14 June, several Member States, in the wake of Germany and Ireland, called for the implementation of the Regulation to be postponed in order to avoid shortages. Some have suggested that the proposed transitional period, which allows certain medical devices to remain subject to the old rules, should be extended to more products and at a later date. The previous European Parliament had also expressed concern about possible delays (see EUROPE 12125/10).
Status of the situation
What is the real situation? "The preparation process is moving forward. But it's a gigantic task. Several fronts are open and we are working to meet the deadlines", we are told by the Commission, pointing out that 23 guidelines have been adopted so far. A coordination group on medical devices, as well as a dozen expert groups (on market surveillance, on the database, on vigilance, on notified bodies, etc.) meet regularly.
Notified bodies. However, Member States and the European Parliament are concerned about the designation of notified bodies. The new rules provide for increased responsibilities for these bodies responsible for issuing the ‘CE’ mark, as well as increased control 'of' and 'by' these entities. But these increased requirements complicate the registration process: before the fraud of adulterated breast implants in 2010, more than 80 notified bodies were operating. Today, the EU has fewer than 60. At the Health Council on 14 June, Commissioner Vytenis Andriukaitis reported that 51 applications for certification had been submitted to the Commission and that 2 bodies had received a positive response: one German and one English representing between them "one third of the market", says the Commission. Due to Brexit, the British notified body BSI has transferred most of its certificates to its subsidiaries and is currently taking steps to have its British entity certified. Two other notified bodies are in the process of obtaining approval. So, in the short term, we should move from two to four certified organisations. At the Health Council, Commissioner Andriukaitis set the target of 20 organisations by the end of the year.
'Eudamed' database: the new rules modernise the database on medical devices, previously known as 'Eudamed2'. However, some uncertainties remain about the degree of transparency of this tool, which will provide a constantly updated overview of the life cycle of products available on the EU market. "We open ourselves to a maximum level of transparency. That being said, if a reported problem is due to the way a device is used or the way it has been implanted, it cannot be said that the device is unreliable. We must therefore carefully check the conclusions we reach", the Commission explains to us. With regard to the timetable, here too, there could be delays, particularly on the monitoring part, since the experts have chosen to focus on the registration part considered more urgent. (Original version in French by Sophie Petitjean)