BSI — Clinical Evaluation Under EU MDR: Requirements and Best Practices
Summary
White paper covering clinical evaluation requirements under EU MDR, including MEDDEV 2.7/1 Rev 4 guidance, clinical evidence expectations, equivalence claims, and how clinical evaluation reports should be structured for conformity assessment.
Document Details
Document IDBSI-CLINICAL-EVAL
TypeNB White Paper
AuthorityBSI Group (NB 2797)
Publication Date2023-01-01