Notified Body Spare Capacity Is A Moving Target And Difficult To Pinpoint
As the medtech industry’s demand for EU notified body auditing services continues to grow, uncertainty continues as to where availability lies. But industry could help testing bodies in their planning.
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New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.
Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.
The regulation of clinical evidence and cybersecurity as well as lack of auditor availability were among the topics causing most concern to the medtech industry in September. But obstacles to the smooth implementation of the Medical Device and IVD Regulations persist and some actors are taking matters into their own hands.