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.

For a complete overview of this consultation procedure, please read the Guideline published in the following section "Related documents".

With particular reference, instead, to the accreditation procedure of Notified Bodies at the AIFA IT systems, please access the information page referred to in the "Related links" box.