Harmonized Standards for Biological Evaluation and Sterilization Published 💥

The Commission Implementing Decision (EU) has been published for MDR (2021/1182) and IVDR (2021/1195) for harmonised standards to support MDR and IVDR (only for Biological Evaluation and Sterilization at this point)

 

🔗 MDR  :  https://eur-lex.europa.eu/eli/dec_impl/2021/1182/oj

🔗 IVDR  :  https://eur-lex.europa.eu/eli/dec_impl/2021/1195/oj

 

#MDRG #mdrguide #IVDR #MDR #medicaldevices #ec

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MDCG 2021-10 – Status of Appendixes E-I of IMDRF N48 under EU Regulatory Framework ✅