On June 5th 2014, Italy enacted the Ministerial Decree of 23 December 2013 – requiring all manufacturers of In-Vitro Diagnostics Medical Devices, intending to place their devices on the Italian market, to have their devices registered on the Italian Ministry of health on-line database.
The NEW Decree was enacted towards improving market surveillance and traceability as well as improving the monitoring of public hospitals and other public sanitary structures.
Which categories of IVDs shall be registred?
- Registration is mandatory for In-Vitro Diagnostic Medical Devices included in Annex II (list A and B) of IVD Directive 98/79/EC and for IVD intended for self-testing.
- For ‘all others’ IVDs, the registration is highly recommended.
All IVDs placed on the Italian market for the first time must complete a Pre-Market Registration. The registration shall include all the relevant data concerning both the manufacturer and the device intended to be placed on the Italian market – these may include:
- Technical File (compliance with Essential Requirements of IVDD 98/79/EC)
- Conformity Certificates (CE/ISO)
- Labels (in Italian)
- Instructions for use (in Italian)
- GMDN code
IVD Registrations and Authorized Representative
The obligations outlined in the new Decree apply to the same subjects indicated in Article 10 of Decreto Legislativo 332/2000 (the Italian Decree transposing the IVD Directive 98/79/EC). Therefore the registration procedure shall be completed:
- The Manufacturer if he is Established in the European Union (Italian or EU)
- The Authorized Representative, established in the European Union and lawfully delegated (by a signed legal mandate) by the manufacturer established outside the European Union. The Authorized Representative will complete the registration procedure through a specific section of the Italian Ministry web portal, dedicated to foreign companies.
At the end of the registration process each product will be attributed a registration numberthat will identify it univocally. Local Legislations, such as this one, are still in practice in Europe (such as in Portugal & Latvia) and strengthen the need for a professional European Authorized Representative present at all times.
If you would like to know more on the new requirements for the Italian regi.stration of In-Vitro Diagnostic Medical Devices contact us.