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AESGP: Despite MDR Failures, ‘Complete Overhaul’ Not Needed

 
• By David Ridley

The Association of the European Self-Care Industry gives EU regulators a to-do list of targeted reforms to save the Medical Devices Regulation from the scrapheap.

European Flags in front of the European Commission Headquarters building in Brussels, Belgium
• Source: Shutterstock

After almost seven years of implementing the EU Medical Devices Regulation, it has become apparent that its objectives have not been achieved, argues the Association of the European Self-Care Industry, AESGP.

“The current regulatory framework under the MDR is characterized by unpredictability, opacity, and resource-intensive processes, posing significant challenges for businesses, particularly small and medium-sized enterprises,” writes the association in a...

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