Medical Device - France

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Competent Authority

Contact Details

Contact name 1
French National Agency for the Safety of Medicines and Health Products (ANSM)
Contact name 2
medical devices and in vitro diagnostic medical devices department
Contact name 3
Phone
(+33) 01 55 87 36 87
Fax
(+33) 01 55 87 37 17
Email General
Email Department
EC.DM-COS@ansm.sante.fr
Address
143/147 Boulevard Anatole France
ZIP/City
93285 Saint-Denis Cedex
Country
France
Additional information

Only a central CA, no local CA in France.           

Clinical Investigation Authorisation / Registration / Notification

Regulatory & ethics bodies involved in approval proccess
Competent Authority/-ies (CA)
Ethics committee(s)
CA - Submission for authorisation mandatory for...
depending on the class of MD and the invasive nature of the clinical investigation- favorable opinion from ethic committee
CE-marked MD used within label are exempted from any notification obligation to CA
Yes
Guidance on submission of application available
Yes
Guidance on submission of application
National legal framework in place
Yes
Applicable national legal framework/reference
Articles L. 1125-1 to L.1125-31 of CSP (french public health code)
Additional information
Before the entered in force of the Medical Device Regulation (UE ), the clinical trials involving medical device were submitted

Submission Format

Online portal

Pending the availability of Eudamed, investigational applications must be sent to ANSM by e-mail to the following address: EC.DM-COS@ansm.sante.fr

Standard application form available
Yes
Standard application form

Standard application forms for clinical investigations requiring authorisation: "Clinical investigation – application form under Medical Device Regulation for the competent authority (ANSM) and the ethics committee (CPP)"
Available on ANSM website: your steps /researcher /request authorisation for clinical investigation   ANSM website 

https://ansm.sante.fr/uploads/2022/03/02/20220302-annexe-2-modele-faec.docx

 

Standard application form - additional information

Files must be submitted in Word or PDF format, signed where applicable

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

Detailed information on submission format is provided in the following guidance documents : 

Notice to sponsors Party 1: https://ansm.sante.fr/uploads/2021/05/31/2021-05-28-aap-partie-i-dispo-generales-ic-dm-v1-2-tqg.pdf 

See also :
Practical details: https://ansm.sante.fr/uploads/2022/02/04/20220204-modalites-pratiques.pdf

 

National legal framework in place
Yes
Additional information

Submission by two channels :  

By  Email :

EC.DM-COS@ansm.sante.fr

Via  Eudralink (EMA)

Language of Submission

Language(s) of application
French
English
English accepted
Partly, not for all documents
Documents mandatory to be in official national language
Documents may be submitted in English; French is nevertheless required for certain documents document
Additional information

Documents which are submitted in French are listed in the following document:

Practical details guidance_Annex 1 : Clinical investigation dossier – List of documents required by ANSM and CPP (document in english) https://ansm.sante.fr/uploads/2022/02/04/20220204-annexe-1-liste-recapitulative-des-documents-exiges-par-lansm-et-les-cpp.pdf

For example there are :

  • protocol synopsis
  • proof of insurance

  • Documents to be used to obtain informed consent

     

     

    Related information is provided in the guidances as refers above 

Submission Fees

Fees for trial submission mandatory
No
Fees

No submission fees 

Applicable national legal framework/reference
Additional information

Timelines Autorisation

General timespan (maw nr days)
60
30 (for class I or IIa MD, other than MD of long term invasive IIa class + MD or IVD MD, having already been the subject of authorisation in France)
Mode of approval
Tacit (Silent)
Explicit authorization only for research relating to MD incorporating products of human or animal origin
Additional information

The processing times for requests are described in the following document:

 "table of classification and process of clinical investigations": https://ansm.sante.fr/uploads/2022/02/10/20220210-classification-et-process-devaluation-des-investigations-cliniques-dm-selon-le-reglement-2017-745-et-adaptations-nationales.pdf 

Validation deadline (validation time to allow applications to be processed) : 10 days (+ 10 days for the sponsor (option of an additional 20 days on reasoned request) and 5 days for ANSM if the dossier is incomplete) A<

Assessment deadline:45 days (+ 20 days if expert consultation) + clock-stop of
clock-stop of 12 days max. 

Amendments/Substantial Amendments

Timeline for approval of SA (max nr days)
60
From date of receipt of valid application
By silent (implicit) approval
By explicit authorization only for research relating to MD incorporating products of human or animal origin
Guidance of submission of SA available
Yes
Applicable national legal framework/reference
Additional information

1: Validation by ANSM / CPP / or coordinated by ANSM
(depending on whether the MS is the responsibility of ANSM / CPP / both) 10 days (+ 10 days for the sponsor and 5 days for ANSM and/or CPP if the dossier is incomplete)

2: Evaluation period: Evaluation by ANSM and/or CPP 38 days (+ 7 days for ANSM) if expert consultation) + clock-stop of 12 days max

Submission format: Electronically (see Application Format). In exceptional circumstances, it is possible to transmit the file of request by post or messenger. 

Safety Reporting

Sponsor must declare reportable events to
National CA
Relevant EC(s)
Reportable AEs
SAE (Serious Adverse Event) - Near Incidents
All suspicions of USADE (Unanticipated Serious Adverse Device Effect)
SUSAR being life-threateningor leading to death must be reported
Immediately
SAE/SADE must be reported
Immediately, within a max of 15d for other reportable events (Suspicions of USADE + SAE likely to be related to the procedure of implementation of MD)
Immediately, for events bieng life-threatening or leading to death
National standard reporting form available
Yes
Standard reporting form

A standard reporting form ('Formulaire 5' & 'Formulaire 6') is available on the ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Formulaires et modèles à télécharger (Forms and Downloads)

Available at : http://ansm.sante.fr/Mediatheque/Publications/Formulaires-et-demarches-Essais-cliniques

Reporting format - options
Electronically
Provision of annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
Relevant EC(s)
Guidance on AE reporting procedure

"Avis au promoters/ Notice to sponsors': Provides detailed information reporting obligations including required contents and format of reports 

Document available on ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Avis aux promoteurs / fiches (Notice to sponsors/ guidelines)

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

Article R. 1123-48 of the CSP
Decree EI  (articles 4 and 8)
Article R. 1123-53 of the CSP (Annual Safety Report)
Decree : Décret n°2017-884 du 9 mai 2017 modifiant certaines dispositions réglementaires relatives aux recherches impliquant la personne humaine

Additional information

These provisions apply to interventional clinical trials carried out on MD and IVD MD

End of trial

End of trial declaration: who, when, what?
All clinical investigations requiring authorisation by CA
Responsible for end of trial declaration
Sponsor
Legal representative
Regular termination - declaration of timespan (max nr days)
90
Timespan counted from
Last participant - last visit in the respective country
Last participant - last visit in all involved countries (multinational trials)
Early/premature termination - declaration timespan (max nr days)
15
Reasons for early termination shall be clearly declared
Yes
Standard declaration form available
Yes
Standard declaration form

Available on the ANSM website in section end of clinical investigation : 21/05/25/fin-doc032-v01-ax1-2021-05-20.docx

To be sent to ANSM by e-mail to: EC.DM-COS@ansm.sante.fr + to the CPP via SIRIPH2G

Guidance on end of trial declaration available
No
Guidance on end of trial declaration

Notice to sponsors in progress
 

National legal framework in place
No
Applicable national legal framework/reference

Article L1125-20 of the CSP

There are no specific provisions in national law.
The sponsor shall inform the competent Data Protection Committee and the competent authority of the start and end of the clinical investigation, in accordance with the procedures laid down in Article 77 of the MDR  (EU).

 

Ethics Committee

Contact Details

Contact name 1
Comités de Protection des Personnes (CPP)
Additional information

39 competent regional (lead) ECs in France (no local ECs). The EC that will review the submission file is randomly selected.

list of EC: https://sante.gouv.fr/IMG/pdf/repertoire_cpp_23042024.pdf

 

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
EC first
Procedural interaction between CA and EC during approval proccess
Yes
Additional information

Submission to EC first because in the application form submitted to the CA, the CPP selected must be indicated. 

However submission to EC and CA the same day.

Single-Centre Studies - Ethical Review

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

There are 39 competent regional ECs in France.

The sponsor submits the application to the EC appointed at random from among the available committees and with the relevant expertise 

Multi-Centre Studies - Ethical Review

Ethical approval (favourable option) required form
Regional EC (authorised to issue a single opinion)
Submission of application required to
Any accredited EC
Additional information

The sponsor submits the application to the EC appointed at random from among the available committees and with the relevant expertise 

Submission of Application

Responsible for study submission
Sponsor
Guidance on submission of application available
Yes
Guidance on submission of application

The required content of the application dossier is provided in Notice to sponsors party II _Annex 1 : Clinical investigation dossier – List of documents required by ANSM and CPP

https://ansm.sante.fr/uploads/2022/02/04/20220204-annexe-1-liste-recapitulative-des-documents-exiges-par-lansm-et-les-cpp.pdf

The additional document to the request for an opinion from the EC described in the appendix to the Order of 2 December 2016 laying down the content, format and presentation procedures for the file requesting an opinion from the EC:

https://www.legifrance.gouv.fr/download/pdf?id=6rHR0rznWmItf5IaRDLRPmWUgvYvfJ3GciREwkWtl3E= 

Available at (only in French)

Applicant's guidance and FAQ: https://sante.gouv.fr/IMG/pdf/guide_deposant_siriph2g_v7_avril_2023.pdf 

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

Submission Format

Format option(s)
Online portal
Preferred format
Not applicable
Online portal
Use of standard application form binding
Yes
Guidance on submission format available
Yes
Guidance on submission format

Online portal- 

Connexion - SI RIPH 2G (sante.gouv.fr)

The required content of the application dossier is provided by cf "sublission of application" 

Arrêté du 2 décembre 2016 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° et au 2° de l'article L. 1121-1 du code de la santé publique portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro (JORF n°0284 du 7 décembre 2016)

Available at (only in French): https://www.legifrance.gouv.fr/eli/arrete/2016/12/2/AFSP1635568A/jo/texte

National legal framework in place

Language of Submission

Language(s) of application
French
English
Preferred language of application
English accepted
Partly, not for all documents
Documents mandatory to be in official national language
Protocol Summary
Information material, Documents and Forms intended for study participants and patient information
Import request form
Documents mandatory to be in language of study participant
Information material, Documents and Forms intended for study participants and patient information
Additional information

Annex 1 : Clinical investigation dossier – List of documents required by ANSM and CPP- the mandatory langage of some documents is indicated

Submission Fees

Fees for ethical review mandatory
No
Fees for ethical review

No submission fees. 

Additional information

Timelines Ethical Review

General timespan for single-centre studies (max nr days)
45
45 j + clock-stop of 12 days max.
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of receipt of valid and complete application
National legal framework in place
Yes
Applicable national legal framework/reference

Amendments/Substantial Amendments

Ethical review mandatory for
Any substantial modifications having a significant impact on any aspect of research
Responsible for submission of SA
Sponsor
Standard notification form available
Yes
Timeline for approval of SA (max nr days)
35
38 days
Applicable national legal framework/reference
Additional information

EC notifies the CA on its decision. 

Safety Reporting

Reportable AEs
SAE (Serious Adverse Event)
SAE (Serious Adverse Event) likely to be related to the procedure of implementation of the MD
SAE (Serious Adverse Event) including AE being life-threatening or leading to death or to a serious deterioration in health, prolonged hospitalisation, additional surgery or medical intervention
SAE (Serious Adverse Event) arising from the testing of the MD
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately
Within a max of 2 d upon first knowledge for events being fatal, life-threatening, or deteriorating health
Within a max of 7d upon first knowledge
Responsible for AE reporting to relevant EC(s)
Sponsor
SAE/SADE must be reported
Immediately, within a max of 7 d upon first knowledge (+8d for additional information) for reportable events being life-threatening or leading to death
Immediately, within a max of 15d for other reportable events (Suspicions of USADE + SAE likely to be related to the procedure of implementation of MD)
Sponsor is obliged to notify all investigators of SAE/SADE occurence
Yes
National standard reporting form available
Use of corresponding form (for AE reporting to CA) possible
Standard reporting form

"Investigation summary safety report form » (MDCG-2020-10/2) available at the following adress : https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020-10- 2_guidance_safety_report_form_en.xlsx 

This table will be updated and sent each time a new event to be reported or new information relating to an event already reported is to be notified. 
Where appropriate, more detailed information should be provided at the request of the ANSM.

Reporting format - options
Email
Online safety reporting portal
not yet
Provision of annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
Not required
Guidance on AE reporting procedure available
Yes
Guidance on AE reporting procedure

 Notice to sponsors: Provides detailed information reporting obligations including required contents and format of reports https://ansm.sante.fr/uploads/2021/11/19/2021-11-16-aap-partie-iv-vigilance-ic-dm-v2.pdf 

 

National legal framework in place
No
Applicable national legal framework/reference

The applicable provisions are those specified in the RDM (Article 80)

For the clinical investigation under article 82 of RDM- the ANSM applies provisions of article 80.5 et .6 du RDM.

Additional information

"Investigation summary safety report form » (MDCG-2020-10/2) available at the following adress : https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020-10- 2_guidance_safety_report_form_en.xlsx 

This table will be updated and sent each time a new event to be reported or new information relating to an event already reported is to be notified. 
Where appropriate, more detailed information should be provided at the request of the ANSM.
Details of the information to be included in this table are given in section 10 of recommendation MDCG-2020-10/1 referred to above.

The concepts of new safety fact and annual safety report (ASR), for which provisions exist in the amended Jardé law, have not been introduced into the MDR and are therefore not applicable to clinical investigations submitted within the framework of the MDR.
However, the sponsor may draw up an ASR or declare new facts to the ANSM.

End of trial

End of trial declaration mandatory
Yes
Responsible for end of trial declaration
Sponsor
Regular termination - declaration of timespan (max nr days)
90
Timespan counted from
Last participant - last visit in the respective country
Last participant - last visit in all involved countries (multinational trials)
2 declarations might be required, if the research does not come to an end simultaneously in France and other countries
Early/premature termination - declaration timespan (max nr days)
15
Reasons for early termination shall be clearly declared
Yes
Standard declaration form available
Yes
Standard declaration form

'Form of declaration of end of trial' ('Formulaire 10'): 
Available on the ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Formulaires et modèles à télécharger (Forms and Downloads)

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

Study Specific Requirement

Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)

The sponsor is the person or entity who takes the initiative of the research on human beings, which ensures the management of this research, and which verifies that its financing is planned.
When several persons or entities take the initiative of undertaking the same research, a single sponsor must be designated to assume the responsibility for the course of the research on national territory.
(Article L. 1121-1 of the CSP)

But, since the entered in force of the MDR, the term of "Sponsor" is defined by the MDR- article 2 (49)

Sponsorship mandatory
Yes
Sponsorship mandatory - Additional information
Co-Sponsor - Definition available in national law
No
Co-Sponsor - Definition (pursuant to national law)
Co-sponsorship allowed
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
Standard IC form (ICF) available
Not specified
IC is regulated by law
No
Informed Consent - Definition/ Requirements

Nos specific national provisions (cf Article L1125-17)

Informed consent is regulated by MDR. 

Legal representative is designated under the national law. 

Applicable national legal framework/ Reference

Article L1125-17 of CSP

Article L1125-21 offense of conducting a clinical investigation without consent 

Study participants - vulnerable population

Minors / Children - Studies allowed
Yes
Special provisions apply
Specific provision

Legal representative of the minor is designated uner the national law

Legal framework/Reference (Minors/Children)

Civil code 

Incapacitated persons - Studies allowed
Yes
Special provisions apply
Legal framework / Reference (Incapacitated persons)
Emergency situations - Studies allowed
Yes
Emergency situation without prior consent of patient or proxy - Studies allowed
Yes
With limitations
Conditions allowing trial participation in emergency setting without prior consent

Provisions of article 68 of the MDR 

Legal representative is designated under the french law

Legal framework / Reference (Emergency Situation)
Pregnant or breastfeeding women - Studies allowed
Yes
Specific provisions
Legal framework / Reference (Pregnant or breastfeeding women)
National legal framework for protection of vulnerable populations in place
Yes
Applicable legal framework / Reference (Vulnerable Population)

Legal representative designated under national law- provisions of civil code

Study participants - compensation & reimbursement

Reimbursement for study participants
Mandatory
Compensation is limited to/provided for
Adults only
A certain amount
Additional Information

The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applicable, compensation for constraints suffered paid by the promoter. The total amount of compensation that a person may receive in any one year is limited to a maximum set by the Order of 15 February 2023 on the maximum amount of compensation for hardship that a person may receive during one same year.

 

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

Mandatory to inform participant of clinical trial outcome
On Patient's request
Additional information

The participants have the right to be informed of the outcome of a clinical investigation

Data protection

Notification to DP Authority/ Ombudsmann is mandatory
Yes
Approval/authorisation required
For some study types
Specific notification timelines before operations start
No deadline
Laguage of notification
Official National Language(s)
Notification format
Online portal
Notification fee required
No
Guidance on notification requirements available
No
Guidance on notification requirements

information on regulatory process may be found on CNIL website www.cnil.fr 

Data protection authority/agency - contact details
Address
8 rue vivienne
ZIP/City
75083 Paris cedex 02
Country
France
Additional information

Notification is required for interventional and observational investigations on MD (and combination studies with MP). 

Archiving & data management

Study documents must be kept at least (in years)
10
15

National Legislations

General Information

Official website providing relevant national legislation available
Yes
Official website providing relevant national legislation

ANSM website (CA) provides applicable regulations and decrees in section:  Your regulatory steps /medical devices/ researcher 

Official governmental legal database available
Yes
Official governmental legal database

Legifrance: public legal database

Investigations on Medical Devices

Act on Medical Devices (or comparable national legal framework)

Clinical trials on MD in France are covered by:
LOI no 2004-806 du 9 août 2004 relative à la politique de santé publique (complétée par le décret 2006-477 du 26 avril 2006).
This law (following the “Huriet - Sérusclat” Law) has to be regarded for all biomedical research involving human beings. It is part of the Code de la Santé Publique/CSP (see: Code de la santé publique - Titre II Recherches biomédicales).        

Additional Information

The documents shall be kept for at least ten (10)years after the end of the clinical investigation concerning the device in question or, if the device is subsequently placed on the market, for at least ten years after the last device is placed on the market. In the case of implantable devices, this period is at least fifteen years (15). (Annex XV chap III RDM).

Data protection

Legal framework (on safeguarding the collection, handling, recording, keeping and/or processing of any clinical trial related data and patient files)
National Data Protection Act
National DP act

Personal data are collected and processed for the purpose of the clinical investigation in compliance with the GDPR and the french data protection law n° 78-17 of January 6th, 1978. This law includes provision concerning health data collecting within clinical research

Insurance

Specific requirements
Applicable legal framework

Definitions

MD/MD Investigation

MD - Definition available in national law
No
MD - Definition

No specific French definition- applicable definitions are  provided by the MDR.  

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