A new document, explores the challenges associated with the five-year re-certification requirement under the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
The paper highlights that continuous monitoring, audits, and post-market activities already fulfil the intended safety objectives — making fixed-period re-certification largely redundant, while introducing additional administrative burden and cost.
Key elements include:
✅ A Q&A format explaining the main questions and concerns
✅ A visual overview of the continuous surveillance system under MDR and IVDR
✅ A comparative table showing how re-certification duplicates existing lifecycle oversight mechanisms