AIFA, as the Competent Authority for medicinal products, may be consulted by a Notified Body for a scientific opinion on ancillary medicinal substances incorporated in Class III medical devices (defined in Annex VIII of EU Regulation No. 2017/745).

To facilitate access to the consultation procedure, the Agency shall make available to the Notified Bodies a guideline defining the procedural aspects, formats and requirements of the dossier.
Notified bodies are bodies designated by a Member State to carry out activities to assess the conformity of medical devices with the requirements of EU Regulation No. 2017/745.

According to EU Regulation No. 2017/745, if a medical device incorporates, as an integral part, a medicinal substance  which has an action ancillary to that of the device, the Notified Body called upon to assess its conformity shall consult a Competent Authority for medicinal products for a scientific opinion.