Author: Suzanne Broussard
The newest guidance documents for post-market clinical follow-up (PMCF) requirements have just been released by the Medical Device Coordination Group (MDCG). The two documents provide guidance templates for the PMCF plan and the PMCF evaluation report to help manufacturers meet the stricter regulatory requirements under Medical Device Regulation (MDR) 2017/745.
These templates should help manufacturers understand more clearly what needs to be included in the PMCF as well as present the information in a harmonized manner. Indeed, these templates provide guidance on the presentation of post-market clinical data to assist notified bodies and competent authorities find information in an organized format.
The PMCF plan template provides a clear outline of the PMCF plan in Sections A through G. The intent is that PMCF is a continuous process designed to “proactively collect and evaluate clinical data from use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.” Presenting all this data in an organized, cohesive, and convincing manner just got a little easier thanks to the PMCF document templates.
The PMCF plan is designed to be implanted and the results documented in the PMCF evaluation report. The link between the 2 is evident by the symmetry in these templates.
The information included in the PMCF evaluation report is used to update a variety of regulatory documents. Indeed, the scope of the PMCF’s impact includes:
- Clinical evaluation, including the clinical evaluation report (CER)
- Risk management documents
- Post-market surveillance plan
- Summary of Safety and Clinical Performance (SSCP)
The PMCF evaluation report template is outlined in Sections A through G. Section’s A and B outline the manufacturer’s contact details (A) and the medical device description and specification (B).
Section C of the PMCF evaluation report provides a template for the manufacturer to report all activities described in section C of the PMCF plan, including which activities were performed, all the clinical data obtained from the completed activities, and justifications of any deviations from the plan. As noted earlier, much of the data gathered and included in the PMCF evaluation report is pulled directly from the protocols outlined in the PMCF plan. In addition, the quality of the data collected must be described.
Sections D outlines the evaluation of clinical data relating to equivalence of the medical device with similar devices. This is the opportunity for organizations to report all clinical data relating to an equivalent device or selected similar device. This includes analysis and conclusions, newly identified hazards that have an impact of the devices benefit-risk determination, the clinical evaluation, and/or PMCF plan. Additionally, any changes to State Of The Art are presented here. Providing these analyses requires careful consideration and extensive expertise.
Sections E expands the results in Section D asking the manufacturer to discuss the aggregate of results in Sections C and D that impact the technical documentation of the CER and risk management file.
Section F outlines the format to present information on the devices adherence to applied common specifications and/or harmonized standards, and/or guidance listed in the PMCF plan. The conclusions are presented in Section G, and they must include any need for preventive and/or corrective measures identified.
In a previous blog post, we talked more about the role PMCF plays in the clinical evaluation report (CER).
If your organization needs more than templates to complete the PMCF plan and evaluation reports, reach out to our expert medical writing team at Criterion Edge.