European Commissioner Stella Kyriakides is on the same wavelength as her predecessor with regard to implementing the new rules on medical devices. In her opinion, there is no need for a longer transition period. However, she approved the request made by Member States at the Health Council on 9 December to report to them more regularly.
Medical devices are products for internal and external use, such as breast implants. In 2017, the EU adopted new rules that tighten control over the auditors themselves (‘notified bodies’). Regulation 2017/745 on medical devices is due to come into force in May 2020, and Regulation 2017/746 on in vitro devices is due to come into force in May 2022.
A readiness check
Yet, as the new commissioner and health ministers jointly acknowledged on 9 December, it is proving to be particularly “difficult” to implement these rules. The Twenty-Eight had already brought this message as early as June 2019; certain Member States—such as Germany and Ireland—had even asked for the application of the rules to be postponed until 2024 by activating a “passerelle” clause.
This time, the ministers limited themselves to supporting a request from Ireland and Sweden in favour of more regular reporting from the Commission as well as a readiness check. Incidentally, the rotating presidency of the Council of the EU, which is subject to an obligation as regards circumspection, widely relayed this message at a press conference. In response to a question from EUROPE, Finnish Minister of Family Affairs and Social Services Krista Kiuru stated: “Industry and a large group of Member States are concerned that key elements are still incomplete. This includes the low number of notified bodies. Finland shares these concerns, but we had a very fruitful discussion on this subject”.
Commissioner Kyriakides optimistic
For her first council in Brussels, Commissioner Stella Kyriakides thus had to directly go into detail in order to try to convince the Twenty-Eight.
As regards notified bodies, she affirmed that nine of them had already been designated in compliance with the new rules and that three others would be by the end of the year. Moreover, she expects that there will be 20 by the first quarter of 2020.
With regard to the Eudamed database (the other major component of this reform), the commissioner acknowledged that there was indeed some delay. However, she also said that this delay has no repercussions on the general implementation of the regulations. “They already foresee an alternative plan in relation to the exchange of information in the absence of Eudamed. And we have started working on the operational details of this plan. During the interim period, we intend to voluntarily make a module for active [product] registration by May 2020”, she affirmed. (Original version in French by Sophie Petitjean)