Two EU Notified Body Frontrunners In Race For Designation Under New Regulations
The latest revelations in London and Brussels over the last week show concrete progress is being made toward the designation of notified bodies. But which organizations will be named first and when?
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The EU's Notified Bodies Operations Group's just issued a best-practice guide on the designation and notification of conformity assessment bodies under the MDR and IVDR. It makes for sobering reading.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.