From 1 December 2021, the national medical device database, established pursuant to Article 13 of Legislative Decree 46/97, has been adjusted from a structural point of view to allow manufacturers and their authorised representatives to fulfil the registration obligations of CE marked medical devices pursuant to EU Regulation 2017/745, until the European Eudamed database is fully operational (Art. 123, paragraph 3, letter d of the Regulation).
Further information on the operation of Eudamed can be found in the section The European Database Eudamed - Implementation in Italy.
