Common Specification Class D for IVDR 💥

A draft of common specifications for Class D devices has been published by the European Commission. This helps to establish requirements for Class D devices with no harmonised standards.

 ðŸ”— Original Document :  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en

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MDCG 2022-3 Verification of Class D IVDs 📚

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FDA proposal to incorporate ISO 13485:2016 into 21 CFR 820 🔗