Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
THOUGH THE deadline for compliance with the EU Medical Device Regulation 2017/745 (MDR) has passed, manufacturers must maintain processes and documentation to preserve their CE marking. The regulation places greater emphasis on post‑market clinical follow-up (PMCF) – an area that requires ongoing attention. Manufacturers were able to opt for an extended deadline of May 2024; however, they are not exempt from PMCF compliance in the meantime. All devices must comply with EU MDR post-market requirements even if they have a renewed certificate under the previous medical device directive (the criteria to benefit from the 2024 deadline).
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