Change for consultation procedures resulting from the implementation of Medical Device Regulation (MDR)
As of 26 May 2020 the Medicines Evaluation Board (MEB) will provide advice under the new Medical Device Regulation (MDR, EU 2017/745), replacing the current Medical Device Directive (MDD; 93/42/EEC). The MEB can only accept applications for consultation procedures submitted under this new regulation from the 1st of December 2019. Pending consultation procedures under MDD, submitted before 1 December 2019, in principle should be finalised before 26 May 2020.
For new consultation procedures, starting after 1 December 2019, the updated application form is available via the MEB website.
The consultation procedure applies to medical devices that contain a substance that is an integral part of the medical device, but that can be used as a medicinal product when used separately.
For any question concerning ongoing procedures the Notified Body is advised to contact the MEB or the case manager of the ongoing procedure.