May 31, 2023

The European Commission publishes the confirmation letter template required to extend the MDD periods

šŸ“¢ The European Commission publishes this confirmation letter template required to apply the extended transitional periods to the MDD

You can download the document here:

Transitional deadlines

Devices

26 May 2026

Class III custom-made implantable devices

31 December 2027

Devices covered by valid MDD/AIMDD certificates (as of 20 March 2023) that are Class III implantable devices, or Class IIb devices excluding well-established technologies (WET)* under the MDR.

31 December 2028

Devices covered by valid MDD/AIMDD certificates (as of 20 March 2023) that are Class IIb devices (excluding non-WET Class IIb implantable devices), or Class IIa devices, or Class I sterile devices, or Class I devices with a measuring function;