04 July 2023 


Francesca Gennari – Chiara D’Elia – Stefano Tramacere 




DECREES OF 20.3.2023 

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.  

The LD 137/2022 is composed of 33 articles and explains the guidelines for the implementation of the MDR in Italy (Article 1). All the definitions used in the Decree 137/2022 coincide with the ones of the MDR Italian translation (Article 2). It states that the competent authority is the Ministry of Health (MoH) but there are some exceptions for instance in case the NANDO (New Approach Notified and Designated Organisations) information system comes into play. In this circumstance it is the competence is of the Ministry of the Economic Development. Sometimes, even the Consumer and Competition Authority (AGCM) could be competent. This could happen in case of unfair commercial practices. Finally, every time the MDR refers to the competent authority for medicines, it will be the Italian Medicines Authority (AIFA). 

The LD transposes almost word by word the MDR contents or it applies the general principles for the national implementation set in the MDR. In fact, the following articles deal with:  

  • the general rules to put medical devices into the market or into service (Article 4); 
  • general requirements of safety and performance (Article 5);  
  • free movement of devices with a special use (Article 6);  
  • custom-made medical devices (Article 7); 
  • information card requirements for transplant donor (Article 8); 
  • medical devices classification and criteria for dispute resolution (Article 9); 
  • surveillance on the accidents which took place after putting the medical device into the market (Article 10); 
  • conformity assessment and derogation authorisations (Article 11); 
  • registration of the economic operators in the EUDAMED electronic system (Article 12); 
  • EUDAMED EU medical devices database (Article 13); 
  • National (medical devices) database (Article 14); 
  • Identification, traceability and nomenclature of devices (Article 15); 
  • Clinical investigations (Article 16) (see infra); 
  • Notified bodies (Article 17); 
  • Conformity CE marking (Article 18); 
  • Market surveillance (Article 19); 
  • Measures of refusal or restriction (Article 20); 
  • Confidentiality (Article 21); 
  • Health technology assessment (Article 22);  
  • Devices trade (Article 23); 
  • Offering for distance sale of medical devices (Article 24); 
  • Counterfeit medical devices (Article 25); 
  • Publicity (Article 26); 
  • Sanctions (Article 27); 
  • Establishment of the fund for the governance of medical devices (Article 28); 
  • Definition of expenditure ceilings (Article 29); 
  • Tariff provisions (Article 30); 
  • Transitional and final provisions (Article 31); 
  • Repeals (Article 32); 
  • Financial Invariance Clause (Article 33) 

It states that further operational provisions are specified through Decrees of the Ministry of Health. 


Provisions aimed at ensuring that persons entrusted with assessing and validating clinical investigation applications or deciding thereon do not have a conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons financing the clinical investigation, and are free from any undue influence 

The decree sets out how to ensure the independence and absence of conflicts of interest of the persons in charge of assessing and validating clinical investigation applications for devices without CE marking and those with CE marking according to Regulation (EU) 2017/745. These persons must be independent of the sponsor, the investigators involved, and the funders of the clinical investigation, and free from any form of improper influence. 

  • Persons in charge of processing clinical investigation applications  

The Ministry of Health (hereinafter MoH), as the Competent Authority, is responsible for designating the persons responsible for the assessment, validation, and decision on clinical investigation applications and related documentation, by Article 70 of Regulation (EU) 2017/745. To ensure proper evaluation, the Ministry may draw on the support of experts, thereby ensuring that enough persons with the necessary skills and experience participate jointly in such evaluations and validations. 

  • Requirements for experts and lists  

Experts must have proven scientific and professional qualifications. They are selected from among employees of organizations carrying out research, health care, or university training, with which the MoH may enter into agreements or conventions. In addition, the MoH can also identify experts through the use of specially prepared lists, following criteria and procedures that are published on its website. 

  • Independence, transparency, and impartiality 

The persons in charge of dealing with clinical investigations applications must carry out their activities independently, transparently, and impartially, without being influenced by any factor that might compromise their judgment. In addition, these subjects must not be in situations of conflict of interest or improperly influenced by sponsors, economic operators, investigators, or other parties involved in the conduct, management, or financing of clinical investigations submitted for evaluation and validation. 

Periodically, on an annual basis, the persons referred to in Article 2 must submit a declaration stating their financial interests and any links that could potentially cause conflicts of interest. This declaration, drawn up using the model available on the institutional website of the MoH, is considered when assigning responsibilities for the evaluation and validation of each clinical investigation. 

  • Obligation to abstain  

Individuals in charge of processing clinical investigation applications are obliged to abstain from participating in the assessment and validation of clinical investigations if they find themselves in situations of conflict of interest, even if potential, or are subject to undue influence. In other words, if a conflict of interest or improper influence could compromise their impartiality, they must refrain from being involved in negotiations or decisions relating to clinical investigations.


Requirements for facilities suitable for conducting clinical investigations, in accordance with Article 62(7) of Regulation (EU) 2017/745 

  •   General conditions for conducting clinical investigations  

Clinical investigations for medical devices, both those without CE marking and those with CE marking in accordance with Article 74(2) of Regulation (EU) No 2017/745, must be conducted in facilities deemed suitable to ensure the health protection of those involved. The conditions that the facilities must fulfil are: 

  • Documented expertise in controlled clinical trials in the specific field of the trial, supported by scientific publications, patents or other evidence of a similar level. 
  • Established and documented use in normal clinical practice, by qualified staff in the facility where the trial takes place, of medical devices of the same type and class as the objects of the clinical investigation. 

The investigators must hold a qualification to exercise a health profession and must be registered in the relevant professional register. 

  • Types of organizations suitable for conducting clinical investigations to demonstrate compliance.  

Clinical investigations to demonstrate compliance of high-risk medical devices (class III or invasive class IIa and IIb devices) must be conducted in facilities with high specialty characteristics such as: 

  • Public hospitals. 
  • University Hospitals and University Polyclinics. 
  • Hospital facilities that have an agreement with universities for the medical-surgical disciplines are covered by the agreement. 
  • Scientific Hospitals and Treatment Institutes. 
  • Directly operated hospital centers of the National Health Service health authorities. 
  • Institutes and equivalent ecclesiastical bodies. 
  • Qualified private health institutes of the NHS health company. 
  • Private nursing homes accredited with the NHS. 
  • Research organizations. 
  • Rehabilitation institutes and INAIL treatment and rehabilitation centers for rehabilitation activities. 

For class I devices or class IIa and IIb non-invasive devices (low-risk class devices), clinical investigations may also be conducted in the following facilities. 

  • Specialist and multi-specialist outpatient facilities of the NHS companies. 
  • Territorial facilities are defined by Ministerial Decree No. 77 of 23 May 2022 and by the specific reference laws. 


  • Certification of requirements 

Possession of the necessary requirements to carry out clinical investigations must be certified by the legal representative of the structure using a declaration, using the model published on the MoH website. It is possible to attach documentation to support the declaration. If the clinical investigation includes activities that take place outside the facility where the investigation is conducted, adequate levels of quality and safety must be guaranteed. Mechanisms must be in place to report and manage any adverse events that may occur outside the organization. The MoH may carry out checks on the declarations submitted and the measures taken to ensure the quality and safety of clinical investigations.