Post-Sales Clinical Follow-up (PMCF) Plan and Template

Post-Sales Clinical Follow-up (PMCF) Plan and Template

Post-market clinical surveillance (PMCF) is recognized by the Medical Device Regulation (MDR) (EU) 2017/745 as an ongoing process that updates clinical evaluation and should be addressed in the manufacturer's post-market surveillance (PMS) plan.

The scope of the PMCF scheme are the methods and procedures established by the manufacturer to proactively collect and evaluate clinical data from human use of a CE marked medical device placed on the relevant market or put into service.

Purpose of the PMCF plan:

• Verifying the safety and performance of the medical device throughout its lifetime, when applicable
• Identifying side effects and monitoring defined side effects and contraindications,
• Identification and analysis of emerging risks,
• Ensuring continued acceptability of the benefit-risk ratio referred to in Annex I to MDR 1 and 9,
• Identifying possible systematic misuse and off-label use of the device to verify its intended use.

Part of the clinical evaluation report and technical documentation, the PMCF evaluation report is a manufacturer's report containing the PMCF analyzes and results. The prepared PMCF plan is evaluated by the notified body. The main purpose of the MDR with the creation of the PMCF plan is to provide guidance to manufacturers to comply with its relevant requirements.