Europe – European Notified Body survey: MDR, IVDR certification numbers remain low

A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), despite pending expirations of their CE Marking under previous Directives.

Conducted by the European Commission’s Medical Device Coordination Group (MDCG), the survey examines Notified Body certification and application activities as the MDR and IVDR take effect. The MDCG has previously issued recommendations for medical device manufacturers to secure MDR compliance in order to avoid decertification and ultimately a potential device supply shortage in Europe, but the new survey results provide significant data highlighting compliance challenges.