On May 26, 2021 the European Union’s (EU) Medical Device Regulation (MDR) became effective. The MDR overhauls how the EU regulates medical devices, including stricter controls for high-risk devices, new risk classification systems for certain devices, and stronger post-market surveillance. Of particular interest is the MDR’s focus on post-market clinical follow-up (PMCF).
Under the MDR, PMCF is now viewed as “a continuous process that updates the clinical evaluation” of a device and must be clearly detailed in each manufacturer’s post-market surveillance (PMS) plan. A manufacturer’s PMCF plan, which must be created for each device in its portfolio should seek to confirm the safety and performance of a device, identify and monitor previously unknown side-effects, keep tabs on emergent risks, identify systematic misuse of the device, and “ensure the continued acceptability of the benefit-risk ratio.” Each PMCF is then subject to assessment by individual notified bodies (country-level regulators). It should be noted that PMCF plans and reports for combination products are assessed by the European Medicines Agency (EMA). The notified body (or EMA) then reviews and either approves or rejects the PMCF on behalf of the European Commission.
In the new world of European medical device regulation, real-world data (RWD) and real-world evidence (RWE) have taken on greater importance than ever before. Well-conducted, rigorous analyses of RWD can provide critical information for many components of a PMCF plan. Indeed, the Medical Device Coordination Group (MDCG), a subcommittee of the European Commission, acknowledges this in its template for both the PMCF plan and PMCF report. Section C of the PMCF plan template discusses how manufacturers should discuss RWD and planned RWE analyses.
Aetion has critically assessed the new medical device landscape and formulated an offering to support PMCF plans and reports. Contact us to learn more or chat with one of our medical device experts.