The EU MDR has increased requirements for clinical evidence throughout the lifecycle of medical devices, particularly for high-risk and implantable devices. Real-world evidence (RWE), derived from real-world data (RWD), is increasingly recognized as an important complement to pre-market clinical investigations and a key component of post-market clinical follow-up (PMCF).

This presentation examines the role of RWE in meeting PMCF requirements under the EU MDR, with a focus on regulatory expectations, methodological considerations, and practical implementation. Cardiovascular devices are used as an illustrative example, as they often require long-term follow-up and robust post-market evidence. Sources of RWE include device and disease registries, electronic health records, patient-reported outcomes, surveys, and retrospective observational studies.

RWE methodologies, particularly registries, enable the assessment of device safety, performance, and benefit–risk profiles in routine clinical practice and broader patient populations. Case examples, including cardiovascular guidewires and coronary stents, demonstrate how RWE can help address clinical evidence gaps for both legacy and innovative devices. PMCF data generated through real-world usage can be fed into device risk management, supporting continuous performance/safety  monitoring as well as meaningful product improvement and innovation.

High-quality, fit-for-purpose RWE, when appropriately integrated into clinical evaluation and PMCF activities,  can play a pivotal role in meeting EU MDR requirements. n December 2025, the European Commission proposed major amendments to the EU MDR. The potential impact on clinical evidence generation and PMCF requirements will be discussed during the presentation.