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