Challenges faced by manufacturers with clinical evaluation under the new European Medical Device Regulations

Abstract

This study seeks to investigate the impact of strengthened requirements for clinical evaluation for medical device manufacturers in Europe due to the new Medical Device Regulations. Qualitative interviews were conducted with eight clinical evaluation consultants from eight different European countries who review and approve clinical evaluation reports for manufacturers prior to their submission to notified bodies. The study describes the sources of device clinical evaluation evidence and describes the consultants’ recommendations and challenges encountered when reviewing Clinical Evaluation Reports. The findings from the study demonstrate that understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant Clinical Evaluation Report. Additionally, the study identified a knowledge and skills gap in the generation and assessment of acceptable regulatory and clinical data. Further, there is heterogeneity in the reviews of Clinical Evaluation Reports received by consultants and inadequate guidance to enable compliance by manufacturers. This study found that some manufacturers of certain CE-marked medical devices are planning to remove them from the EU market upon expiration of their certificate, and in the case of new innovative devices, some manufacturers may launch in other non-EU markets.