Summary
MDR governs medical devices in the EU: classification (I-IV), conformity assessment, CE marking, clinical evaluation, UDI, post-market surveillance.
Scope
Applies to medical devices and accessories as defined in Art. 2 (instruments used for diagnosis, prevention, monitoring, treatment of disease — includes many software/IVD-adjacent products). Determines whether a product is a medical device by intended purpose. Excludes certain products (e.g. cosmetics, food) which have their own regimes.
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Related regulations
Modified by (11)