The information on this page is valid and current as of october 2020. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page. Disclaimer

Regulatory Authority:
Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico – Italian Ministry of Health.

Class I (non-sterile, without measuring function), Class I (sterile, with measuring function), Class IIa, Class IIb, Class III.

Quality system:
In compliance with ISO 13485:2016 technical standard.

Medical Devices shall bear the CE marking and they are subject to registration with the Italian Ministry of Health database.
In the case of a non-European Manufacturer it is necessary to appoint a European Authorized Representative.
Manufacturers intending to market CE-marked Medical Devices in Italy and European Authorized Representatives, in the case of devices produced by Manufacturers established outside the European Union, must register with the Ministry of Health database and notify some technical data of the device, according to specific online forms for the purpose of their inclusion in the Medical Devices Repertoire.

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Authorized Representative or Manufacturer.

Timeframe and fees:
Timeframe: 30-45 days.
Registration in the Italian Ministry of Health database is currently not subject to fees.

Validity of the CE marking: 5 years.

Labeling and documentation language:
Documentation and labelling must be provided in Italian.

Useful information:
The site of the General Directorate of Medical Devices and the Pharmaceutical Service of the Ministry of Health is constantly updated.
Like all the Countries of the European Union, Italy will also adopt the New Regulation (EU) 2017/745 on Medical Devices. It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.

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