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EU Authorities Call For Thorough Analysis To Avoid Medtech Regulation Review Errors

 
• By Amanda Maxwell

Having already voiced their commitment to working to resolve issues with the implementation of the MDR and IVDR, the national competent authorities for medical devices around the EU are now also calling for a longer-term view.

biz challenge
There Are Many Challenges In Improving Medtech Regulations That Need Addressing • Source: Alamy

The EU’s medtech regulatory authorities recognize there is an urgent need to develop and improve the medtech regulatory system, but say that “doing so reactively and without a thorough analysis and evaluation could lead to significant further disruption and impairment to progress towards an effective EU regulatory system.”

“Taking a wrong turn at this point is not an option,” the Competent Authorities for Medical Devices (CAMD) association adds in a

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