MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG publishes IVDR surveillance guidelines MDCG 2022-6, regarding the transitional provision under Article 110(3) of the IVDR. The aim of this guidance document is to provide clarification on the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3).

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.