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raps·Jul 22·1 min read
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MDCG: Only manufacturers should assign UDI-DIs

The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better standardized as they are added to Europe's new clinical trial database the European Database on Medical Devices (Eudamed).

Jul 22, 2026·read at raps ↗Neutral

21 Jul 2026 European Commission publishes guideline on transparency obligations under AI Act The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act, including examples of exceptions to these requirements. While not specific to healthcare products, companies developing healthcare products with an AI system component may be subject to transparency rules. Regulatory News

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