Post-market Clinical Follow-Up

The key components of the PMCF process are as follows: 

• PMCF Plan. This document outlines the methods and procedures for collecting clinical data. Article XIV Part B section 6.2 of the MDR details the specific components manufacturers should include in their PMCF plan. MDCG 2020-7 provides a PMCF plan template.  
• PMCF Activities. Depending on the device these can include clinical studies, devices registries, surveys, and analysis of data from existing sources like scientific literature and adverse event databases. 
• PMCF Report. The manufacturer analyzes the findings from the PMCF activities and documents the results in a PMCF evaluation report, which is part of the technical documentation. The conclusions of the PMCF evaluation report are used to update the clinical evaluation, risk management documentation, PMS plan, and the SSCP, if applicable. MDCG 2020-8 provides guidance for manufacturers on PMCF evaluation report preparation. 

The frequency of updating a PMCF evaluation report depends on the risk class of the medical device. According to Article 61 (11) of the MDR, the PMCF evaluation report must be updated at least annually for Class III and implantable devices. For other classes, updates are required as needed, based on the findings from post-market surveillance activities.

Not every medical device will require PMCF. Article 83 of MDR states that manufacturers must create and maintain a post-market surveillance system proportionate to the risk class and appropriate for the type of device. However, there is no specific guidance on which product groups or classifications this applies to, nor are there examples of such a justification. To determine if PMCF activities are necessary and to what extent, the same approach used for clinical evaluation can be applied. This involves considering the type, novelty, classification, intended purpose, and risks of the device. High-risk and novel devices will likely require a PMCF study. Conversely, devices without an intended medical purpose or where clinical data collection is inappropriate and clinical evaluation is based on Article 61(10) there is no need to collect PMCF data. According to Annex III, Section 1.1(b), if PMCF is deemed not applicable, a justification must be provided as part of the PMS plan.

Manufacturers can perform various types of PMCF activities to ensure the continued safety and performance of their medical devices. As outlined in Annex XIV, Part B 6.2 (a)(b) of the MDR, PMCF methods and procedures can be classified as general or specific. General methods include gathering clinical experience, collecting user feedback, and screening scientific literature and other clinical data sources. Specific methods involve evaluating suitable registers or conducting dedicated PMCF studies. At a minimum, product-specific literature searches must be conducted to obtain data published in peer-reviewed scientific literature. For implantable devices and Class III devices that have not undergone clinical investigations as per Article 61(4), the PMCF plan should incorporate post-market studies to demonstrate safety and performance. 

The PMCF plan should detail all PMCF activities, including both general and specific methods or procedures relevant to the product, as well as their timelines. It must describe the aim of each activity, the rationale for selecting the chosen methods, and any known limitations, such as incomplete follow-up or missing data.