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Manufacturers’ Delaying Tactics With Notified Bodies Threaten To Undermine MDR Extensions

 
• By Amanda Maxwell

There are concerns that practices by manufacturers desperate get one foot in the door at notified bodies could threaten the successful implementation of the EU Medical Device Regulation.

Manufacturers Are Securing Notified Bodies When Insufficiently Ready • Source: Shutterstock

Not enough companies are coming forward yet to notified bodies under the MDR, giving rise to concerns that operational bottlenecks are likely to form in 2027 and 2028 − the very end of the new set of compliance deadlines for legacy products.

This is the view of Françoise Schlemmer, director of the EU notified body association, TEAM-NB, as expressed to Medtech Insight.

Key Takeaways
  • Manufacturers are applying to notified bodies to meet the 2024 deadline but are then asking to delay submitting their quality system and technical documentation for up to...

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