[EU, Conference] Information session on MDR/IVDR for international regulators – 4 July 2024

The EU Regulations on medical devices and in vitro diagnostic medical devices

 

MDR, IVDR

1. Extension of MDR transitional period

    - 31 Dec 2027: class III, class IIb implantable

    - 31 Dec 2028: Other class IIb, class IIa, class I m/s

 

2. Extension of IVDR transitional period

    - 31 Dec 2027: devices covered by IVDD certificate and class D

    - 31 Dec 2028: class C 

    - 31 Dec 2029: class B, class A sterile devices

 

3. Gradual roll-out of EUDAMED

 

 

Information session on MDR/IVDR for international regulators – 4 July 2024 - European Commission (europa.eu)

Information session on MDR/IVDR for international regulators – 4 July 2024

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