Framework
EUMDR — Clinical Evaluation
The EU MDR 2017/745 requires manufacturers to conduct and document a clinical evaluation for every medical device, demonstrating conformity with the General Safety and Performance Requirements through clinical evidence. The regulation specifies the clinical evaluation process, including data sources, assessment methodology, and post-market clinical follow-up requirements.
Overview
Background
Under Regulation (EU) 2017/745, clinical evaluation requirements were substantially strengthened compared to the former directives. The regulation introduced specific clinical evidence requirements by device class, mandatory clinical evaluation consultation procedures for certain high-risk devices, and explicit post-market clinical follow-up (PMCF) obligations, reflecting the critical importance of clinical evidence for device safety.
Applicability
These requirements apply to manufacturers of all medical devices placed on the EU market. The level of clinical evidence required scales with device risk class, with Class III and implantable devices facing the most stringent requirements, including clinical investigation data in most cases. The clinical evaluation must be updated throughout the device lifecycle based on post-market data.