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The PRRC, Software and AI: Compliance Roles for Modern Devices
Two of the hardest questions in medical device compliance today are who takes responsibility, and how the rules apply to software and artificial intelligence. The[…]
EUDAMED and Actor Registration: What Is Now Mandatory
The European database on medical devices has moved from “coming soon” to “required now”. Since May 2026, the first EUDAMED modules are mandatory — and[…]
UDI: Unique Device Identification Explained
Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database — and getting the[…]
Post-Market Surveillance and Vigilance for Medical Devices
Under the MDR, a device is never “done”. Post-market surveillance turns the CE mark into an ongoing obligation to prove — continuously — that the[…]
Notified Bodies and Conformity Assessment Under the MDR
For any device above Class I, a notified body stands between you and the CE mark. Understanding how they work — and why capacity is[…]
Clinical Evaluation and Clinical Evidence Under the MDR
The MDR raised the bar on clinical evidence sharply. “It worked under the old directive” is no longer enough — every device now needs a[…]
Technical Documentation and the GSPR Under the MDR
The technical documentation is the evidence file that proves a device is safe and performs as intended. It is what a notified body assesses, what[…]
Medical Device Classification Under the MDR
Under the EU Medical Device Regulation, everything starts with classification. Get the risk class right and the whole route to market follows logically; get it[…]