New Harmonized Standards for MDR 👍

In an amendment to the Implementing Decision (EU) 2021/1182, a number of harmonised standards have been updated for the following topics:

 -          Symbols for IFU & manufacturer-supplied information

-          Biological evaluation of devices

-          aseptic processing

-          Quality management systems (ISO 13485, to no one’s surprise)

-          Sterilization

🔗 Original Document :  https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32022D0006