The Medical Device Coordination Group (MDCG) has published a template of the post-market clinical follow-up (PMCF) plan to be used by medical device manufacturers to place their devices on the EU market. Due to the legal nature of the document, the provisions stated therein are not binding and should be treated as recommendations to be considered.
In accordance with the Medical Device Regulation 2017/745 (MDR), the PMCF constitutes an important part of the responsibilities of the medical device manufacturer related to post-market surveillance. The aforementioned regulation also implements a set of requirements the PMCF plan should meet. In particular, it should include detailed information about the methods and procedures applied by the manufacturer for the purpose of collecting and assessing clinical data deriving from the ongoing use of the medical device properly placed on the EU market in accordance with its intended purpose.
According to the appropriate MDCG guidelines, the PMCF plan should be used to:
- Confirm that the device meets the applicable safety and performance requirements during the whole lifecycle,
- Identify and monitor side effects,
- Analyze the risks on the basis of the evidence collected,
- Ensure that the benefit-risk ratio remains acceptable,
- Track and identify all cases of misuse or off-label use.
The MDCG also emphasizes the following points:
- As it was already mentioned before, the PMCF plan should be a part of the post-market surveillance plan,
- The results of the PMCF should be processed by the manufacturer and combined into the appropriate PMCF evaluation report,
- The PMCF evaluation report should be included in the clinical evaluation report and technical documentation,
- The PMCF report should be evaluated by the notified body, while the procedures performed by the manufacturer and all related documentation will also fall within the scope of such evaluation.
The present PMCF template has been published by the MDCG in order to provide medical device manufacturers with the additional information useful for achieving and sustaining compliance with the applicable requirements set forth by the appropriate regulations, including the MDR. It is also expected that the use of the present template by the manufacturers would simplify the supervision activity carried out by the notified bodies and national regulating authority in the part of post-market surveillance.
Post-Market Clinical Follow-up Plan Structure
The MDCG guidance describes in detail the structure the PMCF plan should have in order to comply with the applicable requirements.
First of all, the plan should include the main information about the document itself, namely: its number, date, version, and also the history of revision (including the description of changes made).
The PMCF plan itself is divided into seven sections named from A to G respectively.
- Section A provides contact details of the medical device manufacturer. In particular, this part of the document shall contain the legal name of the entity, its address, and SRN, details of the person responsible for regulatory compliance, as well as the information about the authorized representatives.
- Section B is dedicated to the medical device in question. In this section, the manufacturer shall provide the name or trade name of the device, it’s model and type, description of the device, its intended purpose and users, medical conditions in which the device supposed to be used, and also the contradictions and warnings. This section should also contain the list of all accessories intended to be used with the device, the indication of the class of the device together with the reference to the appropriate classification rule, expected lifetime of the device, and Basic UDI-DI.
- Section C shall contain the description of the activities related to the post-market clinical follow-up, including the methods and procedures applied by the manufacturer. In this section, the manufacturer shall indicate the aim of each activity and explanation for the reasons for choosing the particular methods and procedures. The MDCG recommends providing the information about the activities in the form of a summary table containing the following columns: number of the activity, description of the activity, the aim of the activity, rationale, and known limitations of the activity, timelines of the activity.
- Section D shall contain the references to the relevant parts of the technical documentation. In particular, the manufacturer shall make references to the information contained in the clinical evaluation report and risk management file. However, the manufacturer is also allowed to indicate that there is no information to be referred to instead. In case of making references to the clinical evaluation report and/or risk management file, the manufacturer shall indicate the date and version of the appropriate document.
- Section E shall cover the aspects related to the clinical data deriving from equivalent or similar medical devices. According to the regulations, the manufacturer shall provide information demonstrating compliance with the applicable safety and performance requirements during the whole lifecycle of a medical device. For this purpose, the manufacturer may use references to the data deriving from the use of an equivalent or similar medical device. The type of reference (equivalent or similar device) should be also indicated by the manufacturer. The MDCG recommends to provide information in a form of a schedule containing the following columns: name of equivalent/similar device, intended purpose, intended users, intended patient population, medical condition, indication, reference to clinical data evaluation in CER.
- Section F should contain the references to the applicable harmonized standards, common specifications, or guidance documents. For each type of the documents, the manufacturer shall include the title, date, and version.
- Section G should contain the indication of the estimated date the manufacturer is going to submit the post-market clinical follow-up evaluation report.
Description of PMCF Activities
One of the most important parts of the MDCG guidelines is dedicated to the activities to be performed by the medical device manufacturer in the context of post-market clinical follow-up. Each activity should be described by the manufacturer in details, including the following aspects:
- The source of the request for PMCF activity (e.g. an appropriate request from a notified body),
- The detailed description of the activity, including the procedures and methods,
- The aims of the activity,
- The procedures performed as part of PMCF (e.g. post-market studies or surveys),
- The rationale for the appropriateness of the procedures and methods applied by the medical device manufacturer.
- The timelines within which the activity should be performed.
Summarizing the information provided here above, the template issued by the MDCG provides the medical device manufacturers with the most important information regarding the structure and content of the post-market clinical follow-up plan. The document contains non-binding recommendations to be considered in order to ensure the completeness of the document.
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