There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years. One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has just voted this down, which is great news for our industry.
They did agree on some stricter requirements for Notified Bodies, specifically the following:
- 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
These new rules will need to be approved by the EU members states so this is by no means final, but they are expected to have an impact on future AIMD development and approval.