The PMCF plan is to be written under the European Medical Device Regulation EU 2017/745 (MDR) and the Medical Device Coordination Group (MDCG) Guideline 2020-7 unless the manufacturer justifies why a PMCF is not applicable (Annex III.1.b Regulation EU 2017/745). It is part of the clinical evaluation plan (CEP) and the post-market surveillance (PMS) plan and should include all relevant information to conduct PMCF.
PMCF must follow a systematic method, including proactive and reactive actions. Proactive actions are all actions where a manufacturer approaches a source of clinical data based on a defined plan to get access to clinical data on its device (e.g., example: PMCF studies, PMCF surveys, register data reports on demand, evaluations of routine data). Reactive actions are all actions where existing information is evaluated (e.g., example: Data from literature review or public websites like MAUDE or in future EUDAMED).
In addition, PMCF is part of the post-market surveillance (PMS), which collects and evaluates additional data on the medical device by active as well as passive methods. Manufacturers are required to implement and maintain a PMS system that routinely monitors the clinical performance and clinical safety of the device as part of their quality management system.
To collect data for the above-mentioned purposes, the PMCF plan includes general and specific methods and procedures with a rationale for the choice of method(s). General activities have a broader perspective, while the specific methods are aimed at answering distinct questions or aspects. The specific objectives to be addressed by the PMCF and the evaluation of the clinical data are stated. For a comprehensive view of the medical device, clinical data relating to equivalent or similar devices are also considered. References to any relevant common specifications (CS), harmonized standards, and relevant guidance on PMCF are provided. The plan also included a detailed and justified schedule for all PMCF activities.
The clinical data must be regularly analyzed and assessed for:
Conclusions of the PMCF evaluation report, in line with MDCG Guideline 2020-8, are considered for updates to the CER, the risk management system (RMS), the post-market surveillance (PMS) system, the summary of safety and clinical performance (SSCP) and/or Periodic safety update report (PSUR), the labelling or IFU or other product information. If, through PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
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