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=== EU === Medical devices are governed through [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 MDR]. The process of approving medical devices (issuing the [[wikipedia:CE_marking|CE mark]]) itself is performed by various [https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en Notified Bodies]. Medicinal products are governed in various forms by the [https://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinal-products-human-use-eu_en EMA]. Note that this is only one part of the framework, which may involve relevant state-level and other authorities.
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