May 2020 STATE OF PLAY. Please refer to the European Commission website for the latest information:https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/getting-ready-new-regulations_en
EU MDR implementation timeframe:
26 May 2021: Assignment of UDI - all classes (Transition period until 26 May 2025)
26 May 2021: UDI labelling - Class 3 implantable devices
26 May 2023: UDI labelling - Class 2
26 May 2025: UDI labelling - Class 1
Deadlines +2 years for direct marking
EU IVDR implementation timeframe:
26 May 2022: Assignment of UDI - all classes
26 May 2023: UDI marking - Class D
26 May 2025: UDI marking - Class B and C
26 May 2027: UDI marking - Class A
Was this article helpful?
That’s Great!
Thank you for your feedback
Sorry! We couldn't be helpful
Thank you for your feedback
Feedback sent
We appreciate your effort and will try to fix the article