Medical device and in vitro diagnostic manufacturers, along with European notified bodies, are all navigating the unprecedented, tumultuous waters of the MDR and IVDR, with the over-arching goal being patient safety. Bill Enos, from notified body BSI, describes his firm’s experience and strategy, and provides valuable advice for device manufacturers working to certify products in the challenging and rapidly evolving EU environment.
This year marks a historic time in the European medical device regulatory space. The Medical Device Directive (MDD), originally written in 1993 to harmonize the laws relating to the safety and performance of medical devices within the EU, is being replaced by the Medical Device Regulation (MDR; and the new IVD Directive, initiated in 1998). And, notified bodies (NBs)—organizations designated by EU countries to assess the conformity of certain device products before being placed on the market—are working under unprecedented and still-evolving circumstances. As of January 7, there have only been nine MDR (2017/745) and three IVDR (2017/746) designations, compared to a peak of about 80 notified bodies that were operating under the MDD in the early 2010s. According to EU Commissioner for Health and Food Safety, Stella Kyriakides, the goal of 20 NBs is anticipated to be reached during the first quarter of 2020. (See “New EU Health Chief Maintains May MDR Commitment, and Offers Eudamed, Expert Panel Updates,” Market Pathways, December 16, 2019.)
This small handful of organizations is operating amidst a challenging backdrop that includes the looming May 26 MDR deadline, several ongoing designation applications under MDR/IVDR, manufacturers requesting early renewals of Directives certificates (to take advantage of an MDR grace period for devices with a valid CE mark), a busy pipeline of MDR applications including for higher-risk products, and a general increase in regulatory oversight and scrutiny of NBs by designating authorities.