MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

EU IVDR News ( Article 110)

MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect of their quality management system.