EU Medical Device Regulation

Directive European Union · 2017

The EU Medical Device Regulation (Regulation (EU) 2017/745, MDR) governs the safety and performance of medical devices placed on the European market, and — critically for digital health — brings much Software as a Medical Device (SaMD) into scope. It requires CE marking, clinical evaluation, a quality management system (typically ISO 13485), risk classification, and post-market surveillance. Fully applicable since 2021, it replaced the older Medical Devices Directive and raised the bar for any software that diagnoses, monitors, or informs clinical decisions.

Sectoral regime. It binds the industries below; companies outside them generally fall outside it.

Countries

Where this binds. Each links to the providers apis.io has catalogued there.

austriabelgiumdenmarkestoniafinlandfrancegermanyirelanditalynetherlandspolandportugalspainsweden

Regions

europedachfrance iberianordicsbeneluxitaly southern europecee

Industries

Each links to that industry as a scored cohort — so the question "how ready is this sector for the regime that governs it?" becomes one you can actually look at.

healthcarelife sciencesdigital healthbiotechnology
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