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.
Here are the links to the 2 newest PMCF guidance documents:
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:
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.
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.
Author: Suzanne Broussard
Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible 1-year extension for the application of MDR might give manufacturers a little wiggle room to achieve compliance, but not much.
The European Commission (EC) states in a nutshell that one of the reasons for the new regulations is to strengthen post-market surveillance requirements for manufacturers.
The goals for these new regulations are to:
The EC considers these newest regulations as providing extremely important improvements to modernize the current system and, therefore, medical device manufacturers need to make every effort to be compliant or risk further delays in obtaining a CE marking for their device.
In a recent post, we discussed one of the most challenging areas in the CER: Defining Measurable Safety and Performance Endpoints.
The PMCF plan must establish processes that proactively and systematically collect information from a variety of sources. These sources include serious incidents, Periodic Safety Update Reports (PSUR), field safety corrective actions, inputs on non-serious injury, undesirable side-effects, trend reports, literature, databases, registers, feedback and complaint sources form users, distributers and importers, as well as publicly available information on similar medical devices (MDR 2017/745, Annex III).
The PMCF plan should document the method in which the PMCF should be performed. Therefore, the PMCF plan needs to specify the methods and procedures that will be used by the manufacturer to proactively collect the clinical data and the data’s subsequent evaluation. The plan’s aims are to:
Choosing the post-market data to be collected in the PMCF plan is not an easy or straightforward task. The plan must include pertinent parameters to ensure the device is safe and effective. However, including too many or irrelevant variables may result in low response rates and/or missing data. The manufacturer should also consider that some data will be visible to the public. Indeed, one of the goals of the new regulations is to introduce transparency into the system to keep the general public informed, allowing patients to be more engaged in making their healthcare decisions.
The PMCF plan plays a central role under MDR 2017/745 since it lays the groundwork for the PMCF studies that subsequently interface with PSUR, Summary of Safety and Clinical Performance (SSCP), risk management files, CER updates, labeling, and IFU.
The data acquired through the application of the PMCF plan can provide strong evidence as to the safety and efficacy of the device and details about the clinical risks associated with use. Analysis of these post-market clinical data in combination with clinical literature is a powerful tool for manufacturers to improve product performance and support claims to regulatory agencies.
Getting these done is very time consuming and requires significant expertise, especially since the PMCF plan is an integral part of the quality system under MDR. The level of specificity necessary for the methods and protocols is intense.
The PMCF Plan must, at the very least, include the following:
At Criterion Edge, we understand how important the PMCF plan is to the success of your device’s new or annual CER and, thus, ultimately compliance with regulatory authorities and marketing in the European Union. Our experienced medical writers can provide guidance and expertise on the PMCF plan or any other aspect of your CER. If your organization needs expertise or just some breathing space for your medical writers, please reach out to us to chat.