Transition period for Class 1 Medical Devices

01/16/2020

The European Commission has approved a corrigendum to the Medical Devices Regulation (MDR) that includes a transition period for certain class 1 devices.

Class 1 products can remain on the market until 26 May 2024 if they are approved under the Medical Device Directive (MDD) before 26 May 2020 and hold a Declaration of Conformity requiring review in accordance with MDR by a notified body for reasons of classification or other.

See the EU Corrigendum to the regulation on medical device

A transition period has also been introduced for submitting data on custom-made medical devices in the EUDAMED database. The EUDAMED database is not expected to be ready until 2022.

For more information, please contact:

Brian Svend Nielsen
bsn@remove-this.dhigroup.remove-this.com
Tel +45 4516 9140

Back

Transition period for Class 1 Medical Devices

The European Commission has approved a corrigendum to the Medical Devices Regulation (MDR) that includes a transition period for certain class 1 devices.

Services

Read more