MDCG clinical evaluation assessment report (CEAR) guidance published

Notified bodies use a clinical evaluation assessment report (CEAR) to clearly document the conclusions of its assessment of the clinical evidence presented by medical device manufacturers in clinical evaluation reports (CERs) and associated documentation. The assessment of clinical evidence is a core requirement of the Medical Device Regulation (MDR, 2017/745).

Use of a harmonised CEAR template provides a standardised method for documenting the notified body’s assessment of the manufacturer’s clinical evaluation and related documents, and this new guidance document, MDCG 2020-13, provides a 24-page checklist and template for notified bodies to use to document their assessment of the clinical evidence provided in a consistent and methodological manner.