Two ministerial decrees were published in the Official Gazette of 13 June 2023 concerning:
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the administrative procedures of national relevance for the presentation of clinical investigation applications for i devices not CE marked or CE marked but used outside their intended use;
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the administrative procedures of national relevance for communications relating to clinical investigations on CE marked devices used within their intended use.
These are two decrees provided for by legislative decree n. 137/2022 (in paragraphs 2 and 3 of article 16), issued to adapt national legislation to the provisions of regulation (EU) 2017/745.
The decrees, which will enter into force on 13 July 2023, are structured in a similar way, with the aim of
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identify the subjects entitled to submit applications and send communications relating to clinical investigations
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clarify the procedures for submitting clinical investigation requests and communications
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define the methods and times for acquiring the opinion valid at national level expressed by an Ethics Committee
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define the methods for communicating the start of investigations.
Two other ministerial decrees were published in the Official Gazette of 14 June 2023, which deal with:
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the independence, transparency and impartiality of entities in charge of handling clinical investigation requests
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i facility requirements suitable for carrying out clinical investigations conducted to demonstrate the conformity of medical devices.
These two decrees, which are immediately applicable, also implement the provisions of legislative decree n.137/2022 (paragraphs 5 and 8 of article 16).
The first Decree has the purpose of guaranteeing the absence of conflicts of interest and undue conditioning for the subjects in charge of handling clinical investigation requests on the basis of specific declarations and the obligation to abstain in the event of a conflict of interest.
Furthermore, to ensure that the evaluation of the survey questions is carried out jointly by an adequate number of people who possess the necessary qualifications and experience, the possible use of experts with proven scientific and professional qualifications is envisaged, to be selected among the employees of institutions that carry out research, health care or university training activities.
The second Decree provides that the assessment of the suitability of healthcare facilities to carry out investigations takes place on the basis of declarations presented by the legal representatives of the facilities and establishes the conditions to allow remote testing of devices that can be used thanks to the use of digital technologies.
Consultation:
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Decree 04/12/2023
Administrative procedures of national relevance for the presentation of the application for clinical investigation for medical devices not bearing the CE marking pursuant to art. 16, paragraph 2 of the legislative decree n. 137 of 2022. (GU General Series, n. 136 of 13/06/2023) -
Decree 04/12/2023
Administrative procedures of national relevance for the presentation of communications relating to clinical investigations for devices bearing the CE marking used within the scope of their intended use pursuant to art. 16, paragraph 3 of the decree n. 137 of 2022. (GU General Series, n. 136 of 13/06/2023) -
Decree 03/20/2023
Requirements of structures suitable for carrying out clinical investigations, in compliance with the provisions of art. 62, paragraph 7 of regulation (EU) 2017/745. (GU General Series, n. 137 of 14/06/2023) -
Decree 03/20/2023
Provisions aimed at ensuring that the persons in charge of evaluating and validating the clinical investigation applications or of taking a decision on them do not suffer from conditions of conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons who finance the clinical investigation and are exempt from any undue influence. (OJ Serie Generale, n. 137 of 14/06/2023)