Notified Body Interactions

A few years ago, there were over 80 Notified Bodies that had the authorisation to audit and certify medical devices. Today there are fewer than 55 and that number is estimated to drop further. 

Besides a reduced number, some of the Notified Bodies are also narrowing the scope of their activities. Especially with the MDR coming into effect in May 2020, this will leave many manufacturers at risk regarding the continuation of their CE and ISO certification.