The postponement of European Regulation 2017/745 (EU) enforcement was voted on 17 April 2020 by the European Parliament. It has now to be approved by the Council of the European Union and then published in the Official Journal (EUOJ).

This is expected by the end of April / beginning of May

Please note:

– To date, there is no information on the way Notified Bodies will handle this extension of the transitional period. Therefore, we recommend you to contact your Notified Bodies to get more information.

– No postponement of the date for affixing the UDI on the labelling of medical devices. – No postponement of the end of CE certificates validity issued under Medical Device Directive (MDD) 93/42/EEC (27/05/2024)

– No postponement of the end date for making available or putting into service medical devices under MDD (27/05/2025)

#medicaldevices #eumdr #caliceos #consulting

 

The postponement of European Regulation 2017/745 (EU) enforcement was voted on 17 April 2020 by the European Parliament. It has now to be approved by the Council of the European Union and then published in the Official Journal (EUOJ).

This is expected by the end of April / beginning of May

Please note:

– To date, there is no information on the way Notified Bodies will handle this extension of the transitional period. Therefore, we recommend you to contact your Notified Bodies to get more information.

– No postponement of the date for affixing the UDI on the labelling of medical devices. – No postponement of the end of CE certificates validity issued under Medical Device Directive (MDD) 93/42/EEC (27/05/2024)

– No postponement of the end date for making available or putting into service medical devices under MDD (27/05/2025)