IVDR Guidance Published Until Eudamed is Fully Functional
IVDR Guidance Published Until Eudamed is Fully Functional. Read a short summary here and find the link to the publication
IVDR
New IVDR Notified Body in Slovakia
New IVDR Notified Body in Slovakia: 3EC International has been approved to undertake IVDR conformity assessments.
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).
Extension of Delegated Powers MDR & 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.
