Europe - Jan/Feb 2020

• EU: Corrigenda to MDR and IVDR are approved

• EU: EUDAMED delayed by two years

• EU: Several MDCG guidance documents have been finalised

• Finland: Finnish Medicines Agency assumes control of devices and IVDs and issues new fee schedule

• Germany: National legislation to implement European MDR passes Federal Cabinet

• Germany: New Digital Care Law entered into force on 1 January 2020

• Germany: DIMDI and BfArM merger expected in first quarter of 2020

• Netherlands: MEB now only accepts consultation procedure applications under Regulation (EU) 2017/745

• Switzerland: Failure to sign an MRA could result in ‘third country’ status

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