Notified bodies in Italy
Look up medical device manufacturers, authorised representatives, importers, and system producers registered worldwide.
A notified body assesses higher-risk medical devices and issues the CE certificates required to place them on the EU market.
11 Notified bodies in Italy registered in EUDAMED
Role and obligations in EUDAMED
A notified body is a conformity assessment organisation designated by an EU member state to assess medical devices before they are placed on the market — auditing manufacturers and issuing the CE certificates required for higher-risk devices (MDR 2017/745, Chapter IV; IVDR 2017/746).
Medical device companies in Italy
Top locations in Italy: Milano, Roma, Napoli, Torino, Padova.
Competent authority in Italy
Medical devices placed on the market in Italy are overseen by its national competent authority for market surveillance: Ministero della Salute.
Frequently asked questions
What is a notified body?
A notified body is an organisation designated by an EU member state to assess the conformity of medical devices before they are placed on the market, under the MDR (2017/745) or the IVDR — règlement (UE) 2017/746.
How are notified bodies designated?
A notified body is designated by the competent authority of an EU member state after a joint assessment; its designation scope (MDR and/or IVDR) is published in NANDO and recorded in EUDAMED with its four-digit identifier.
Where are these notified bodies based?
Notified bodies are established in EU and EEA member states; you can filter this list by country.