MDCG 2021-27 – Q&A on Articles 13 & 14 of MDR/IVDR ❗️

The Medical Device Coordination Group #MDCG has released the MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.  The document primarily deals with Importers and Distributers

 🔗 Original Document :  https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-27_en.pdf

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EU 2021/2282 Regulation on Health Technology Assessment 🆕

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MDCG 2021-28 – Substantial Modification of Clinical Investigation under MDR 🆕