MDCG 2020-12 : Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues – June 2020

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.