Revised MDCG 2022-9 on ‘Summary of safety and performance template’
Revised MDCG 2022-9 on ‘Summary of safety and performance template’
In April 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-9 Rev.1 providing a summary of safety and performance template for in vitro diagnostic medical devices under the IVDR.
For more, see the Commission’s webpage on guidance.