Medical Device - Italy

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Competent Authority

Contact Details

Contact name 1
Ministry of Health - Direzione Generale dei Dispositivi Medici e del servizio Farmaceutico (DGDMF)
Contact name 2
Office 06: Sperimentazione clinica dei dispositivi medici
Contact name 3
Director Pietro Calamea
Phone
+39 06 59942669
Email General
p.calamea@sanita.it
Email Department
N/A
Address
Viale Giorgio Ribotta, 5
ZIP/City
00144 Rome
Country
Italy
Additional information

Clinical Investigation Authorisation / Registration / Notification

Regulatory & ethics bodies involved in approval proccess
Ministry of Health
Ethics committee(s)
CA - Submission for authorisation mandatory for...
All research projects involving humans
CE-marked MD used within label are exempted from any notification obligation to CA
No
Guidance on submission of application available
Yes
National legal framework in place
Yes
Applicable national legal framework/reference
  • Medical Device Regulation EU 2017/745
  • DL 05/08/2022 n.137
  • MoH decree 12/04/2023
  • MoH decree 20/03/2023
  • DM 26/01/2005
  • MoH decree 07/08/2012
  • DM 16/01/2019
  • Regulation (EU) 2016/679
  • MoH decree 06/08/2021

 

Submission Format

Online portal
Standard application form available
Yes
Standard application form

The online form is available on the Ministry of Health website for Notification of clinical trials:

(1) with CE-marked MD (PMCF - Post Market Clinical Follow up):  https://www.salute.gov.it/portale/moduliServizi/dettaglioSchedaModuliServizi.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb=SC&idSrv=POST2&flag=P 

(2) with non-CE-marked MD (pre market): 

Standard application form - additional information
Use of standard application form binding
Not applicable
Guidance on submission format available
Yes
Guidance on submission format
National legal framework in place
Yes
Applicable national legal framework/reference

Language of Submission

Language(s) of application
Italian
English
English accepted
Yes
Documents mandatory to be in official national language
Not specified

Submission Fees

Fees for trial submission mandatory
Depends on request
Fees

Submission fee for authorization requests: € 2.245,20 (free for PMCF)

Waiver for academic (non-commercial) studies possible
Not specified
Payment requirements (timelines)
Prior to submission of application
Official guidance on required fees available
Yes
Official guidance on required fees
National legal framework in place
Yes
Applicable national legal framework/reference
  • MD 26/01/2005
  • MoH decree 07/08/2012

  • MD 16/01/2019

     

Additional information

Timelines Autorisation

General timespan (maw nr days)
60
Mode of approval
Explicit (written)
Tacit (Silent) for PMCF
Clock-stop possible if complementary information requested
Yes
National legal framework in place
No
Additional information

If the study is a post-market trial (CE-marked use within label, class I, IIa and IIb) only a notification of the start to MoH is required. 

Amendments/Substantial Amendments

Standard notification form
Timeline for approval of SA (max nr days)
Not specified
Additional information

Safety Reporting

Sponsor must declare reportable events to
MoH
Investogator/PI shall separately report any SAE/SADE to CA
Yes
Reportable AEs
AE (Adverse Event)
SAE (Serious Adverse Event)
SUSAR being life-threateningor leading to death must be reported
Immediately
SAE/SADE must be reported
According to timelines specified in DM 26/01/2023
National standard reporting form available
Yes
Standard reporting form

Reporting of SAE/Incidents should be done according to the templates provided to this link https://www.salute.gov.it/DispoVigilancePortaleRapportoOperatoreWeb/ 

Reporting format - options
Electronically
Online safety reporting portal
Provision of annual safety report mandatory
No
Annual safety report shall be provided by sponsor to
Not specified
Guidance on AE reporting procedure available
Yes
Guidance on AE reporting procedure

MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745

https://health.ec.europa.eu/system/files/2022-11/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf 

National legal framework in place
Yes
Applicable national legal framework/reference
Additional information

The international standard ISO 14155:2020 (Clinical investigation of medical devices for human subjects - 
Good clinical practice) applies to all clinical investigations of MD. 

For more information: https://www.salute.gov.it/portale/dispositiviMedici/dettaglioContenutiDispositiviMedici.jsp?lingua=italiano&id=26&area=dispositivi-medici&menu=vigilanza 

End of trial

End of trial declaration: who, when, what?
Not specified
Responsible for end of trial declaration
Sponsor
Regular termination - declaration of timespan (max nr days)
Not specified
Timespan counted from
Not specified
Early/premature termination - declaration timespan (max nr days)
Not specified
Reasons for early termination shall be clearly declared
Not applicable

Additional Information & Specifics

Ethics Committee

Contact Details

Contact name 1
The Law no. 3 of 2018 establishes the limit of 40 territorial ethic committees (TECs) and 3 national ECs.
Contact name 2
Country
Italy

Ethical Review - General

Submission for Ethical review mandatory for
All clinical investigations of MD
Submission to CA and EC to be performed in the following order
In parallel
Procedural interaction between CA and EC during approval proccess
Yes
Procedural interaction - additional information

The submission to CA is mandatory for phase I, II, III e IV with medicinal products

Single-Centre Studies - Ethical Review

Ethical approval (favourable opinion) to be obtained from
Local EC
Additional information

art. 6 - Lgs. decree 211/2003

Multi-Centre Studies - Ethical Review

Ethical approval (favourable option) required form
Local EC connected to the coordinator (coordinating EC)
Submission of application required to
All local ECs of participating sites
Additional information

art. 7 - Lgs. decree 211/2003

Submission of Application

Responsible for study submission
Sponsor
Entitled to study submission
Sponsor
Prerequisites for submission
Appropriate insurance
Guidance on submission of application available
Yes
National legal framework in place
Yes

Submission Format

Format option(s)
Email
Paper hardcopy
Preferred format
Not specified
Online portal

N/A

Standard application form available
No
Standard application form - additional information

Depending on the local EC requirements.

Use of standard application form binding
Yes
Guidance on submission format available
Yes
Guidance on submission format

It depends on the local EC.

National legal framework in place
No
Additional information

European Regulation N. 536/2014

Language of Submission

Language(s) of application
Italian
English
English accepted
Yes
Documents mandatory to be in official national language
Not specified
Documents mandatory to be in local language of study site
Not specified
Documents mandatory to be in language of study participant
Not specified

Submission Fees

Fees for ethical review mandatory
Yes
Fees for ethical review

€ 4.000,00 – to 7.000,00 

Official guidance on required fees available
Applicable national legal framework/reference

Timelines Ethical Review

General timespan for single-centre studies (max nr days)
30 - non invasive class I and class IIa-IIb MD; 45 - invasive class IIa-IIb and classe III
General timespan for multi-centre studies (max nr days)
30 - non invasive class I and class IIa-IIb MD; 45 - invasive class IIa-IIb and classe III
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of submission of valid application
National legal framework in place
No
Additional information

European Regulation 2017/745 (MDR)

Amendments/Substantial Amendments

Ethical review mandatory for
Any substantial amendments
Responsible for submission of SA
Not specified
Standard notification form available
No
Standard notification form
Timeline for approval of SA (max nr days)
38
Guidance of submission of SA available
National legal framework in place
No
Additional information

Safety Reporting

Reportable AEs
SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Investigator shall report SAE to
Not specified
Reporting timeline
Not specified
Responsible for AE reporting to relevant EC(s)
Sponsor
Principal Investigator
SUSAR being life-threatening or leading to death must be reported
Not specified
All other SUSAR must be reported
Not specified
SAE/SADE must be reported
Not specified
Sponsor is obliged to notify all investigators of SAE/SADE occurence
Yes
National standard reporting form available
Not specified
Guidance on AE reporting procedure available
No
Guidance on AE reporting procedure
National legal framework in place
No
Additional information

SAE/SADE must be reported to EC(s) for interventional clinical investigations on MD.

End of trial

End of trial declaration mandatory
Yes
Responsible for end of trial declaration
Sponsor
Regular termination - declaration of timespan (max nr days)
Not specified
Timespan counted from
Not specified
Early/premature termination - declaration timespan (max nr days)
Not specified
Additional information

The sponsor shall declare the end of the trial (preliminary or scheduled) to the CA and the ECs.

Study Specific Requirement

Sponsor - Definition available in national law
No
Sponsorship mandatory
Yes
Sponsorship mandatory - Additional information
Co-Sponsor - Definition available in national law
No
Co-sponsorship allowed
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes

Investigator

Entitled to be principal investigator
MD
Standard IC form (ICF) available
Not specified
Standard IC form (ICF)
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements

Same rules as for medicinal products apply. 
European Regulation 536/2014.

Study participants - vulnerable population

Minors / Children - Studies allowed
Yes
Pediatric National EC
Specific provision
Legal framework/Reference (Minors/Children)
Incapacitated persons - Studies allowed
Yes
Legal Representative for patients unable to express the informed consent
Specific provisions

Same rules as for IMP trials

Legal framework / Reference (Incapacitated persons)
Emergency situations - Studies allowed
No national legal framework available
Specific provisions

Same rules as for IMP  trials.

Emergency situation without prior consent of patient or proxy - Studies allowed
Not specified
Pregnant or breastfeeding women - Studies allowed
No national legal framework available

Study participants - compensation & reimbursement

Reimbursement for study participants
Optional
Compensation is limited to/provided for
No specific provisions

Study participants - recriutment & trial outcome >> end of study

Mandatory to inform participant of clinical trial outcome
Case by case

Data protection

Notification to DP Authority/ Ombudsmann is mandatory
No
Approval/authorisation required
No
Specific notification timelines before operations start
Not specified
Notification format
Not specified
Data protection authority/agency - contact details
Italian Data Protection Authority DPA - Garante per la Protezione dei Dati Personali
Phone
+39 06.696771 and +39 06.69677.2917
E-mail
rp@gpdp.it
Web address
protocollo@gpdp.it and urp@gpdp.it
Address
Piazza Venezia 11
ZIP/City
00187 Rome
Country
Italy
Additional information

Archiving & data management

Study documents must be kept at least (in years)
25
National legal framework in place
No
Additional information

European Regulation 536/14

National Legislations

General Information

Official website providing relevant national legislation available
Yes
Additional information

The national legislation related to medical device studies is less specific than the legislation concerning IMP trials. 

Investigations on Medical Devices

Applicable national regulations
Transposition of EU Directives on MD
Transposition of Directive 90/385/EEC

https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=88953 - Legislative Decree n.137 (5 august 2022).

Transposition of Directive 93/42/EEC

https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=88953 - Legislative Decree n.137 (5 august 2022).

Transposition of Directive 98/79/EC

https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2022-08-05;138~art18 - Legislative Decree n.138 (5 august 2022) on in vitro diagnostic medical devices 

Other applicable regulations / implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

Combination studies (IMP/MD)

Applicable national regulations
Legal framework for both study types must be considered
Legal act applicable to both study types

Radiation & Radiotherapy

Specific framework available
Yes
Applicable legal framework

For the use of devices emitting radiation:                      
Legislative Decree 17 March 1995 nr 230 modified by 
- Legislative Decree 26 May 2000 n. 187, 
- Legislative Decree 26 May 2000 nr. 241, and 
- Legislative Decree 9 May 2001 nr. 257

Biobanking

Specific framework available
Applicable legal framework

UNI/ISO 20387 Biotechnology and Biobanking  General requirements for biobanking elaborated by the Working Group 2 (WG2) of the ISO/TC 276 Biotechnology e on August 2018

Data protection

Legal framework (on safeguarding the collection, handling, recording, keeping and/or processing of any clinical trial related data and patient files)
No national legal framework available
National DP act
Other applicable regulations (covering DP related issues)

European Regulation 2016/679

Insurance

Specific requirements

EC operations/ Fees

Separate legal framework available

CA operations/ Fees

Separate legal framework available

Definitions

MD/MD Investigation

MD - Definition available in national law
Yes
MD - Definition

According to the Regulation 2017/745, art.2:

‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, 

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.