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Should The EU Establish A Central Accountable Managing Structure For Medical Devices?

 
• By Amanda Maxwell

Top regulatory experts are reacting to German industry calls for action over MDR/IVDR failures, including a proposal to have a centralized governance agency modeled on the European Medicines Agency but specifically for devices.  

Pros and cons concept. Business man with cardboard plus and minus symbol signs.
Medtech Debates Pros And Cons Of Centralized Agency Again

The question of whether there should be an EU centralized medtech agency to oversee the regulation of medical devices has come to the fore again because of what many consider to be a fundamental failure of the implementation of the Medical Device and IVD Regulations.

And this issue is dividing opinions. 

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