MDR & Medical Device Coordination Group (MDCG) guidance: PMCF and Risk The MDR does foresee a risk-based approach to PMCF. Per Preamble (33), the clinical evaluation process is closely interlinked with risk management, which aims to mitigate any residual clinical risk.
• Article 61.1 specifically outlines that the manufacturer shall specify and justify the level of clinical evidence to demonstrate conformity with the relevant general safety and performance requirements, and “that level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.”
• Article 61.4 explicitly states that high risk devices shall require clinical investigations for conformity assessment, except in certain circumstances as outlined in the Regulation. Given the focus of the present paper, high risk devices will not be discussed here.
• Annex XIV, Part B outlines the PMCF process and provides examples of both general methods and specific methods to support PMCF, including feedback from users, gathering of clinical experience, screening of literature, suitable registers, PMCF studies, etc.
MDCG 2020-7 highlights various examples of activities related to PMCF, including but not limited to registry data, PMCF studies, real-world evidence (RWE), and surveys. The importance of well-defined and structured PMCF activities, including from sources other than PMCF investigations, is also highlighted in MDCG 2024-10 with regard to clinical evaluation of orphan devices.