The law that governs placing medical devices on the EU market. It classifies devices by risk, sets general safety and performance requirements, defines conformity assessment routes, most involving a notified body, and places obligations on manufacturers and other economic operators for technical documentation, clinical evidence, unique device identification, registration, post-market surveillance and vigilance. In vitro diagnostic devices follow a parallel regulation.
This is a summary, not legal advice. Confirm every point against the official text before relying on it, and ask counsel whether it applies to a particular product, transaction, shipment or party.
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