We would like to take this opportunity to inform our customers and other economic operators that companies that have introduced and certified a QM system in accordance with DIN EN ISO 13485:2016 must apply the amendments to the standard and convert their certificates by 26 May 2024. At this time, the transition period ends. The conversion of the certificates to the new version of DIN EN ISO 13485:2021-12 takes place in the regular monitoring process.
Compared to DIN EN ISO 13485:2016-08 and DIN EN ISO 13485 Corrigendum 1:2017-07, the following significant changes have been made in the 2021 version:
- Corrigendum 1:2017-07 has been incorporated;
- Annexes ZA, ZB and ZC have been replaced by the new informative Annexes ZA and ZB, which describe the relationship between the contents of EN ISO 13485:2016 and the General Safety and Performance Requirements of the MDR (Medical Device Regulation) ;
Furthermore, there have been unspecified linguistic and editorial revisions.
If you have any questions regarding QM or CE according to MDR, please do not hesitate to contact us.