Plan PMCF activities

PMCF activities should be linked to the device’s clinical questions, residual risks, and evidence gaps. Common activities include surveys, registries, follow-up studies, literature monitoring, complaint trend review, or targeted clinical data collection.

The plan should define objectives, methods, timelines, responsibilities, acceptance criteria, and how results feed back into the CER, risk management, PMS, and labelling.

If no PMCF activity is proposed, document the rationale carefully. The expert will check whether that position is credible for the device, claims, risk profile, and available evidence.