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How The MDR Is Making The EU Competitively Backward

 
• By Amanda Maxwell

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.

Silhouette woman to jump over obstacles over precipice between rocky mountains A Step to success at background sunset pastel.

When it comes to guidances supporting the implementation of the Medical Device Regulation, major issues are being created because there is “no real possibility for industry to actively and meaningly engage in drafting EU guidances” and provide input on how to make the new system work efficiently, Elizabeth Gfoeller, corporate director, regulatory affairs at MED-EL, an EU manufacturer of globally marketed hearing loss solutions, told the first day of the meeting on 13 September.

This is one of several issues making Europe “competitively backward” when it comes to the regulation of medtech products, Gfoeller...

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