Revised EU Guidance on Clinical Evaluation

In June 2016, the EU published a revised version of the guidance document on Clinical Evaluation. This version, MedDev 2.7/1 Rev. 4, published in June 2016, includes significant changes from the previous version.

The new version is effective immediately, but it not clear how it would affect existing Clinical Evaluation reports.

However, section 6.2.3.a provides information on the frequency of clinical evaluation updates.

  • The clinical evaluation is actively updated:
    • when the manufacturer receives new information from [post market surveillance] that has the potential to change the current evaluation;
      • if no such information is received, then
        • at least annually if the device carries significant risks or is not yet well established; or
        • every 2 to 5 years if the device is not expected to carry significant risks and is well established, a justification should be provided.

When involvement of notified bodies is required, updates are usually coordinated with the notified body. Typically, they are aligned with the timetable for surveillance audits and the renewal of the certificates.