1. Medtech Insight

EU Pushes Faster Route For Innovative And Orphan Devices

 
• By Amanda Maxwell

Existing legislation already offers a route, albeit rarely used, for orphan and innovative devices to reach the market more quickly. It should be used more; manufacturers and notified bodies do not need to wait for official changes to the EU’s medtech regulations.

Man Walking Through Door And Crossing To Other Side Of Gap
Finding a way to help orphan and novel devices onto EU market • Source: Shutterstock
Key Takeaways
  • The EU lacks a dedicated regulatory body and clear pathway for novel and orphan devices.
  • Notified bodies can issue conditional conformity certificates which may limit sales or shorten validity periods.
  • Conditional certificates involve risks, requiring thorough premarket reviews and vigilant post-market surveillance.

The EU notified body industry association, TEAM-NB, is advising that notified bodies make more use of the legislative route that allows them to issue certificates with specific conditions,

Existing guidance, like MDCG 2024-10, which supports clinical evaluations for orphan devices, and aligns with

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