Clinical evidence is not just a regulatory requirement — it is the backbone of patient safety

Hospital corridor with two blurred medical staff members walking past a row of wheelchairs and a potted plant.

At our recent RAPS session in Lisbon, one message clearly emerged: under MDR (EU) 2017/745, clinical evidence is a continuous lifecycle process that depends on the strength of the entire ecosystem.

One critical, and often underestimated, element is the role of Ethics Committees and healthcare institutions.

Ethics Committees sit at two key “gates” of the MDR clinical evidence cycle:

Pre-market investigations (Art. 62)
Post-market PMCF investigations (Art. 74)

Yet, in practice, these roles are not always fully recognized or supported. Limited medical device expertise, regulatory grey zones, and a legacy mindset rooted in pharmaceutical frameworks can lead to misclassification of studies and, ultimately, to weaker clinical evidence.

At the same time, hospitals and HTA bodies are not just users of devices — they are primary generators of real-world evidence. PMCF data collected in clinical practice are essential to confirm safety and performance, especially where device–patient interaction cannot be fully captured pre-market.

However, this requires capabilities we still too often lack:

structured PMCF-ready data collection systems
alignment with MDR evidence requirements
awareness at the level of hospital leadership and research governance

Without these elements, evidence gaps emerge — often becoming visible only during conformity assessment.

Clinical evidence is only as strong as its weakest link.

Strengthening MDR implementation means investing not only in data, but in capability, awareness, and accountability across Ethics Committees, hospitals, manufacturers, CROs, and notified bodies. Because ultimately, patient safety depends on all of us.

Blurred hospital ICU with medical monitors in the foreground and two healthcare workers attending a patient in the background.

Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.

Clinical evidence is not just a regulatory requirement — it is the backbone of patient safety

CE Marking of Medical Devices in accordance with MDR

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