European Parliament Votes Focus on Tighter Rules for Medical Device Notified Bodies

The European Parliament has voted in favor of implementing stricter requirements for Notified Bodies, but not for recommended medical device registration reforms that would create an approval process similar to Premarket Approval in the US.

Proposals for more centralized control of the European medical device market, made by the European Commission’s Environment, Public Health and Food Safety Committee (ENVI) last month, drew swift opposition from industry groups such as Eucomed. The proposals would create more difficult CE Mark certification and medical device registration processes particularly for small and medium-sized manufacturers, Eucomed argued, and MEPs seemed to agree.

Rules the European Parliament did approve include:

  • Notified Bodies must maintain in-house staff members rather than subcontractors to assess medical devices for CE Marking
  •  A new group of Notified Bodies should be formed to evaluate higher-risk devices (such as implants)
  • More access to medical device clinical data for patients and healthcare providers
  • New requirements for reprocessing single-use devices
  • Separate legislation addressing IVD safety

The heavy lifting is not over, though: The new rules must be reviewed and approved by EU member states, where industry concerns about burdensome regulations will come up against national governments eager to minimize the risk of another PIP breast implant scandal happening.

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