POLICY BRIEF  

04 July 2023 

08 

Chiara D’Elia – Stefano Tramacere

THE ITALIAN IMPLEMENTATIONS OF MDR and CTR

And the italian MINISTRY OF HEALTH

DECREES OF 12.04.2023

This policy brief focuses on the Ministerial Decree published on 12 April 2023 and enforceable from 13 July 2023 onwards. This decree specifies the Legislative Decree (LD) No 137 of 2022 on the implementation of clinical investigations for devices bearing the CE marking used in the contest of their intended use.

MINISTRY OF HEALTH – DECREE 12 April 2023
Administrative modalities of national relevance for the submission of communications relating to clinical investigations for devices bearing the CE marking used in the context of their intended use referred to in Article 16(3) of Decree No 137 of 2022

The decree, in force from 13 July 2023, covers:
• Scope of Application: The administrative procedures for submitting communications relating to clinical investigations of CE-marked medical devices must be sent to the Ministry of Health (MoH) until the European Medical Device Database (“Eudamed”) is fully operational.
• Entities Entitled to Submit Reports: Clinical investigation reports must be submitted by the sponsor, who is responsible for the clinical investigation, or by authorized representatives of the sponsor. The obligation to produce documents relating to the representation is also mentioned when requested by the MoH.
• Submission of Communications: The clinical investigation documentation must comply with the provisions of Reg. (EU) 2017/745 and the provisions of Legislative Decree No. 137 of 5 August 2022 and its implementing decrees. It describes the use of templates published on the website of the MoH for sending communications and emphasizes that communications must be made exclusively via information and communication technologies. It also states that the MoH applies the guidelines of the National Italian Agency for Digital for the formation, management, and storage of electronic documents.
• Acquisition of a Nationally Valid Opinion from an Ethics Committee: Communications regarding clinical investigations must be made after obtaining a favorable opinion from a territorial or national ethics committee, as appropriate.
Initiation of Investigations: The sponsor or its authorized representative must notify the MoH of the initiation of investigations within 30 days. For clinical investigations involving additional, invasive, or burdensome procedures compared to the normal conditions of use of the device, the notification must be sent at least 30 days before the start of the investigation.

MINISTRY OF HEALTH – DECREE 12 April 2023

Administrative modalities of national relevance for the submission of the application for clinical investigation for medical devices not bearing the CE marking referred to in Article 16, paragraph 2 of Legislative Decree No. 137 of 2022

The decree, in force from 13 July 2023, covers:

  • Scope of Application: The decree establishes the administrative arrangements of national relevance for the submission of clinical investigation applications and all communications for devices not bearing the CE marking and for those bearing the CE marking referred to in Article 74(2) of Regulation (EU) 2017/745 and the arrangements for the exchange of information relating to the validation of applications and related assessments, the granting of authorizations and their notification, until the European Database for Medical Devices (“Eudamed”) is fully operational.
  • Entities entitled to submit clinical investigation applications: Applications and all communications relating to investigations are submitted by the sponsor, who is the holder of the obligations relating to the clinical investigation and the recipient of communications from the competent authority. If the sponsor is not established in the EU, it must designate a representative in the EU space. Communications with the competent authority may be carried out by authorized representatives. If the sponsor is not the same as the natural or legal person responsible for manufacturing the device under investigation, s/he/ must indicate the identity of that person.
    • Eligible persons established in the EU: certify their qualities by means of declarations in lieu of affidavits only if they are Italian or EU citizens or legal entities, partnerships, organizations, associations, and committees having their registered office in Italy or in one of the countries of the European Union;
    • Eligible persons not established in the EU: certify their status by means of certificates or attestations issued by the competent authority of the foreign State, accompanied by an Italian translation certified by the Italian consular authority to be in conformity with the original.
  • Submission of applications and communications: The models adopted by the Medical Device Coordination Group are used for the submission of applications for clinical investigations and their annexes. Submission of applications and communications must take place using information and communication technology. The MoH follows the guidelines of the National Italian Agency for Digital for the formation, management, and storage of electronic documents.
  • Acquisition of a Nationally Valid Opinion of an Ethics Committee: Applications for clinical investigations and notifications of their substantial modifications must be accompanied by a favorable opinion of a territorial ethics committee or national ethics committee. Measures of the MoH to initiate clinical investigations can only be taken in the presence of an unconditionally favorable opinion of the ethics committee.
    • Class I devices and class IIa and IIb non-invasive devices: Opinion within 30 days after validation of the application;
    • Invasive class IIa and IIb devices and class III devices: Opinion within 45 days of validation of the application;
    • Substantial changes: Opinion within 38 days from the date of notification and in any case before implementation of changes.
  • Beginning of Investigations: The sponsor or the entity duly authorized by the sponsor must give prior notice to the competent authority of the initiation of investigations.
    • Class I devices and Class IIa and IIb non-invasive devices: the notification must be made after the 30-day period has expired;
    • Invasive class IIa and IIb devices and class III devices: communication may be transmitted only after the notification of the authorization by the Ministry of Health.