Implementation of the Medical Device Regulation postponed until 26 May 2021
Due to the coronavirus crisis the European Commission has postponed the implementation of the new Medical Device Regulation (MDR, EU 2017/745) until 26 May 2021. This regulation is going to replace the current Medical Device Directive (MDD, 93/42/EEC). As a consequence, the MEB will still process applications for consultation procedures under the MDD, which are submitted before 1 November 2020. This means that they can, in principle, be completed before 26 May 2021. Variations can be submitted under the MDD until 1 January 2021. From 1 November 2020 onwards the MEB will only process applications for consultation procedures which are submitted under the new regulation.
For new consultation procedures which start from 1 November 2020 onwards you can use the new application form on the MEB website. In addition to the new application form you will also find updated information about medical devices.
The consultation procedure applies to medical devices which contain a substance that is an integral part of the medical device, but which would be a medicinal product when used separately.
For questions about current procedures, the notified body can contact the MEB or the case manager of this procedure.