All 15 of the views provided by the IVD expert panel under the IVD Regulation’s Performance Evaluation Consultation Procedures (PECP) by the end of January 2022 were prompted by submissions of just two notified bodies – BSI Netherlands and TÜV-SÜD Product Service.
An expert panel view is provided in the context of the PECP, which is an additional element of conformity assessment by notified bodies for specific high-risk IVDs (IVDR Article 48.6).
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?