Scoping Out Notified Bodies: Looking Beyond the MDR Designation Count

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Much attention is directed at the dearth of notified bodies designated to work under the EU Medical Device Regulation, but to accurately gauge system readiness device firms really need to pay mind to the detailed “scope” of each designation and, ultimately, to each body’s capacity to take on more clients.

The industry’s anxious watch over notified body designations under the EU Medical Device Regulation has taken on the feel of a slow-moving spectator sport. A new designation or two shows up in the European Commission’s NANDO database once every few months, and cheers and congratulations erupt from all corners of the EU regulatory community—on social media, and elsewhere.


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