Yuri Ceragioli -

The Regulation EU 2017/745 (MDR) will enter into force in one month and with it the European database EUDAMED will also come into force. The full application of the EUDAMED Database will be a gradual process, as the EUDAMED database has several functionalities and only a part of them will be available starting from May 2021.

Many companies are wondering what will happen to the national medical device databases, currently implemented by many EU countries, including Italy.

As regards Italy, currently no official positions have been taken by the Italian Ministry of Health; the Italian Medical Device database will continue to be fully functional and active also with the entry in force of the MDR.

It is possible that the database will be updated in the future for a better alignment with the new regulatory framework, but even on this aspect there are currently no specific indications from the Italian Ministry of Health.

Even after the entry in force of the MDR, companies will still be required to register in the Italian Medical Device database all the device distributed in the Italian territory and to keep updated the information uploaded into the database.

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