Post-Market Clinical Follow-up is steadily becoming a main element of conformity with the EU MDR.
Post-Market Clinical Follow-up (PMCF) is not an entirely new concept. It was originally introduced in the EU Medical Device Directive 93/42/EEC (MDD) with guidance on this requirement provided through MEDDEV 2.12/2 rev.2. The EU MDR builds on this concept further, with PMCF being mentioned over 50 times within the Regulation. In fact, PMCF has become one of the most essential sections of a compliant technical file, showing the organisation’s willingness and commitment to obtaining high-quality clinical data to continually assess a device’s safety and performance within the post-market stage.
A PMCF Plan should be drafted up for each medical device within a manufacturer’s organisation; the terminology used within the MDR leaves very little wiggle room for manufacturers to avoid conducting any sort of PMCF.
The MDR splits PMCF activities into either General or Specific Methods, with General Methods involving activities such as collecting post-market feedback (e.g. complaints and vigilance data, low-quality user surveys), whilst Specific Methods offer a more proactive approach at gathering relevant clinical data on the device in question (e.g. clinical investigations, device registries, high-quality surveys). MDCG 2020-6 provides an excellent ranked list of different activities which can be conducted.
The EU has released guidance on the templates to be used to develop a PMCF Plan and PMCF Evaluation Report, in MDCG 2020-7 and MDCG 2020-8 respectively. However, expectations for PMCF are quite high under the MDR, and this has been an obstacle which some organisations have found difficult to address. Advena has the knowledge and experience required to put together a solid PMCF Plan required to comply with EU Regulation.
Get in touch today to see how we can help you further in developing your PMCF for your device portfolio
