|Theme||Specific additional procedures|
|Target audience||Notified Bodies, Manufacturers|
|Products concerned||· Devices containing a substance which may be considered a medicinal product and which has action ancillary to that of the device
· Devices manufactured utilising tissues of animal origin which are susceptible to transmissible spongiform encephalopathy (TSE)
|Regulatory references||MDR (EU) 2017/745
Annex IX section 5.2 and 5.3.2
Regulation (EU) 722/2012
This document explains what the Notified Body must do during the first certification to the Regulations for devices which already underwent a consultation under the directives:
- For MD which incorporate a substance which may be considered as a medicinal product, and whose action is ancillary to that of the MD, the Notified Body must seek a scientific opinion from a national competent authority or EMA (European Medicines Agency) for the medicinal product part before issuing a certificate of conformity.
- For MD manufactured utilising tissues of animal origin which are susceptible to transmissible spongiform encephalopathy (TSE), the Notified Body must, through their competent authority of its, carry out a consultation of the other competent authorities and the Commission before issuing a certificate of conformity.