New EU requirements for CE marks are making it harder for manufacturers to get new marks when registering or re-registering products.
Medical device manufacturers are facing more significant hurdles in the EU because of tougher clinical data requirements and the steep drop in the number of Noticed Bodies available to approve medical devices for sale in the EU.
Higher standards under the EU’s Medical Device Regulations (MDR) have cut the number of Notified Bodies from 87 to 57 since last year and up to 15 more are expected to drop out this year. Waiting lists for product approvals are now longer, and some CE marks have been suspended without warning or have not been renewed in time, according to Gert Bos, executive director and partner at Qserve Group in the Netherlands. — Jeff Kinney