In an amendment to the Implementing Decision (EU) 2021/1195, harmonized standards that were added/updated include:

 -          EN ISO 11737-1:2018  -  Sterilization of health care products

-          EN ISO 13408-6:2021  -  Aseptic processing of health care products

-          EN ISO 13485:2016  -  Medical devices – Quality management systems

-          EN ISO 15223-1:2021  -  Medical devices – Symbols to be used with information to be supplied by the manufacturer

-          EN ISO 17511:2021  -  IVD – Requirements for establishing metrological traceability

🔗 Original Document :  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0015&from=EN