The RAPS Regulatory Conference Europe 2019
kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the tight timeline remaining before the deadline for full implementation of the MDR and other challenges.
RAPS Executive Director Paul Brooks set the tone for the discussion as he emphasized that planning for the unknown, navigating grey areas and adjusting regulatory strategy along the way is the essence of what regulatory professionals do. At the same time, Brooks acknowledged that the current uncertain regulatory environment makes this perhaps one of the most challenging periods ever for Europe’s healthcare products sector. Throughout the ensuing discussion, panelists returned to the concept of ‘navigating the grey.’
The lack of notified bodies (NBs) designated under the new regulations remains a major concern among panelists. Only one NB has been officially designated so far, although the European Commission’s Erik Hansson revealed that a second designated NB will be announced shortly. It was also revealed that 47 NBs have applied to date, 38 under MDR and nine under IVDR.
Another key takeaway from the opening session, according to panelist Gert Bos
of Qserve, who is also RAPS President-Elect, is “the fact that authorities are working on a plan B,” though “not necessarily the Commission, because they have no way to extend the timelines.” Various national authorities are working together, looking at possible ways certain medical devices could stay on the market under national laws or exemptions, said Bos.
There was a general acknowledgment among panelists that all stakeholders—authorities, NBs, industry, etc.—are learning together how to make the switch from the old directives to the new regulations. Industry leaders emphasized that it is essential for device and IVD manufacturers to prepare as much as possible despite the current lack of NBs or the absence of needed guidance.
Another big issue among pharmaceutical companies raised during the discussion is article 117 of MDR on medicines with an integral medical device. The European Medicines Agency (EMA) is working to clarify NB involvement in such products. Brexit adds another element of complexity as, historically, consultations of devices with medicines have been completed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Despite concerns about the implementation timeline and other challenges, most agreed that the MDR will bring benefits, including greater transparency, Unique Device Identifiers and a new Eudamed.
The opening plenary discussion panel included Bos and Hansson, as well as Bassil Akra, TÜV SÜD Product Service GmbH; Oliver Bisazza, MedTech Europe; Sabina L. Hoekstra-van den Bosch, Central Committee for Research Involving Human Subjects; Graeme Tunbridge, MHRA; Valerie Nys, Federal Agency of Medicines and Health Products, Belgium; Maren von Fritschen, European Confederation of Pharmaceutical Entrepreneurs; Waldo Weijers, Medicines Evaluation Board, Netherlands and Armin Ritzhaupt, EMA.