Starting from 26 May 2020 the ‘College ter Beoordeling van Geneesmiddelen (CBG)’ will be giving advice according to the new Medical Device Regulation (MDR, EU 2017/745). Starting from 1 December 2019, the CBG only handles requests for consultation procedures submitted according to this new regulation. The current requests for medical devices, submitted before 1 December 2019, should be completed before the 26th of May 2020.
For new consultation procedures, starting on 1 December 2019, the new request form can be used, which can be found on the website of CBG.
The consultation procedure applies to medical devices containing a substance integrated in the medical device, but which can be used separately as a medicine.