ARTICLE SUMMARY:
Stella Kyriakides took over as the lead EU official on health policy December 1. She engaged publicly on implementation of the Medical Device Regulation this week for the first time in her new role, in this week's top medtech policy news pick from MedTech Strategist Market Pathways.
[For more details on the health commissioner’s presentation to the Council, as well as a complete roundup of medtech policy news and deeper analysis of the sector, check out Market Pathways.]
Stella Kyriakides affirmed the European Commission’s commitment to launching the Medical Device Regulation next May and responded to complaints about delays of the Eudamed database during her first public engagement as EU health commissioner before the Council of the EU.
“It is a very challenging implementation process, but we are fully committed to ensuring effective implementation of this legislation and to not postpone the deadline,” she said during a December 9 briefing before the Employment, Social Policy, Health and Consumer Affairs Council, made up of EU member state health ministers. “This is very important for ensuring patient safety.”
EU’s leadership changed hands December 1, when Germany’s Ursula von der Leyen took over as president of the Commission based on elections held earlier in the year. Von der Leyen shifted primary responsibility for MDR implementation from the Commission division, or “directorate-general,” that addresses markets and economic growth policy (DG GROW) to the Commission’s health DG (DG SANTE). That means Kyriakides, the Cyprus native tapped by von der Leyen to serve as commissioner of Health and Food Safety, is the new MDR point person.
Kyriakides suggested the European Commission will make an “actor registration” Eudamed module available for voluntary use by next May.
MDR was not the headline topic up for discussion at the December 9 meeting convened by the Council.It was a late addition to the agenda in response to concerns from EU member states about the status of implementation and, in particular, the Commission’s recent decision to delay the launch of the Eudamed medical device database until 2022, two years after the MDR takes effect. European nation leaders are worried, without at least some parts of the planned database available when the MDR kicks in in May, that each country will be burdened with filling in the gaps to support information exchange and that compliance to the new regulation will be challenging.
The database is intended to house information on medical devices, device companies and other “economic operators,” clinical and safety data, and more information to improve transparency and product surveillance in Europe. Kyriakides maintained that the delay of Eudamed until 2022 is necessary to ensure the full system’s readiness, and she pointed out that the MDR (and the IVD Regulation) anticipated the potential for a delay in the database.“The two regulations already foresee an alternative plan in relation to the exchange of information in the absence of Eudamed. We have started working on the operational details of this plan.”
Kyriakides, however, did appear to signal a concession to complaints about having no EU-wide registration system in time for the MDR go-live date on May 26. She suggested the Commission will make an “actor registration” module available for voluntary use by next May.
Ultimately, there was broad consensus among health ministers at the Council briefing that the Commission should commit to convening a “comprehensive readiness check” in early 2020 with all MDR stakeholders to prioritize implementation steps. They also requested that the Commission’s Medical Device Coordination Group work closely with national competent authorities to publish a joint implementation by next April at the latest.
But Kyriakides avoided making any specific commitments. “I think it is a priority for all of us,” she concluded. “We will continue to update the Council frequently and also work within the Medical Device Coordination Group intensively over the next few months.”