Device regulation and market access
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This branch covers the regulatory frameworks and market-access routes for medical devices, organised by jurisdiction after the shared definitions and comparisons with medicines. Investigation documents, clinical evaluation, post-market surveillance and rules for particular device types sit outside this branch.
- What counts as a medical device — definitions, intended use and risk classification
- How device regulation and documents compare with a medicine's — evidence, lifecycle, vocabulary, regulatory categories, document counterparts and technical knowledge
- How the EU trial and device regulations compare — scope, responsibility, study definitions, registration, disclosure and effects on each industry
- The EU Medical Device Regulation — changes, transition, conformity assessment, notified bodies, transparency and proposed revisions
- Clearance and approval routes in the United States — classes, investigational exemptions, routes to market, the meaning of clearance and writing for FDA reviewers
- Labelling and promoting a device in the United States — label and labelling, intended use, IFU terminology, benefit claims, naming, misbranding and promotional review
- Placing a device on the Swiss market — Swiss regulation, representatives, investigation approval, registration, conformity assessment and post-market oversight