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.

Extension of Delegated Powers MDR & IVDR?

Extension of Delegated Powers MDR and IVDR?

Extension of Delegated Powers MDR and IVDR? – The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows.