{"id":21032,"date":"2022-06-20T16:41:26","date_gmt":"2022-06-20T14:41:26","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=21032"},"modified":"2022-06-20T16:41:26","modified_gmt":"2022-06-20T14:41:26","slug":"italy-approved-draft-of-the-national-decree-adjusting-to-mdr-ivdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/06\/20\/italy-approved-draft-of-the-national-decree-adjusting-to-mdr-ivdr\/","title":{"rendered":"ITALY: approved draft of the national decree adjusting to MDR\/IVDR"},"content":{"rendered":"\n
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During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national legal framework to MDR (UE) 2017\/745 and IVDR (UE) 2017\/746. <\/p>\n\n\n\n

As defined by article 15 of Enabling Act No. 53 of 21 April 2021, this decree implements and adopts within the legal system the regulations\u2019 general principles for certain regulatory aspects of interest, from clinical investigations to post-marketing surveillance, vigilance and market surveillance activities.  <\/p>\n\n\n\n

Although not yet approved, it is useful to\nanticipate some of the issues highlighted by the decree. <\/p>\n\n\n\n

Advertising: controls according to Article 7<\/strong><\/h2>\n\n\n\n

The advertising prohibition remains for custom-made and prescription medical devices (devices for professional use).
For other devices, on the other hand, the requirement for prior authorisation<\/strong> for advertising remains, which is issued following the procedure currently foreseen by the Competent Authority but considering the additional requirements set out in Article 7 MDR (EU) 2017\/745 and IVDR (EU) 2017\/746.<\/p>\n\n\n\n

The latter is an important element considering that an analysis of the adequacy of the content of the manufacturer’s declarations will be carried out, in terms of the declared intended use and actual performance of the device.
<\/p>\n\n\n\n

For regulating advertising to healthcare professionals, on the other hand, nothing has been defined, but the Ministry will publish future guidelines<\/strong> to regulate the process.<\/p>\n\n\n\n

Eudamed and national database
<\/em><\/strong><\/h2>\n\n\n\n

Among the Decree’s prescriptions concerning Eudamed and the national database already set up by the Italian Ministry of Health as the Competent Authority to supervise devices placed on the market in the territory are:<\/p>\n\n\n\n