Regulatory Authority
Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico – Italian Ministry of Health.
Classification
Class I (non-sterile, without measuring function), Class I (sterile, with measuring function), Class IIa, Class IIb, Class III.
Quality system
ISO 13485:2016
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.
Applicant
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
Validity of the CE marking: 5 years.
Labelling 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.
