The National Agency for the Safety of Medicines and Health Products (ANSM) of France published on October 24th, 2022, a writing guide for clinical trials requests. The purpose of this set of recommendations is to bring clarity about the intricate process of fulfilling a request and the necessary procedure to start a clinical trial in France, as well about the medical devices that will be used in a clinical trial.

Recommendations:

1. About clinical trial categories:

– To help qualify/classify a study, a Sponsor may contact the Guichet innovation et Orientation [(GIO) Innovation and Orientation desk] of ANSM or by email EC.DM-COS@ansm.sante.fr.

– Concerning additional difficult and/or invasive procedures, a Sponsor must provide detailed information about these procedures in order to receive the authorization from CPP.

– For more details about difficult and/or invasive procedures please follow the guide.

2. About protocol:

– Sponsor must clarify/specify if the ISO 14155 standard has been applied or to justify why it has not been applied. Medical devices must comply with international guidelines, such as ISO 14155 (see (64) of European Regulation 2017/745).

– Concerning safety and vigilance in clinical trial, the protocol must comply with European regulation 2017/745.

– Definition and the declaration for serious adverse events related to investigatory procedure and medical device: for more information.

– GDPR compliance.

– Inform consent must be explicit.

– All the above must be signed by the producer and PI or study coordinator.

3. About CE marked devices used during clinical investigation (experimental medical device or comparator):

– Must comprise the CE/EU declaration of conformity, a user manual and CE/EU mark that must be sent together with the clinical trial request file.

– The CE/EU mark must be valid and refer to the medical device for the entire clinical trial.

– The commercial notice for the medical device must have a CE marking and the declaration of conformity for the same medical device as the one with the commercial marking.

4. About the clinical evaluation plan:

– A sponsor must provide a clinical evaluation plan in conformity with the Appendix IV – Part A of the European regulation 2017/745, or to justify why it has not been provided.

– The above are applicable for research categories 1, 2, 3, 4.1 and 4.2 (except for institutional promoters).

5. About the post-marketing clinical follow-up plan:

– If the research falls into the categories 1, 2, 3 et 4.1, a post-marketing clinical follow-up plan must be provided.

– the MDCG 2020-7 guide can be consulted.

6. About the section of the certificate of contact between the CPP and the ANSM:

– Sponsor must be aware that for approving clinical studies he must be in contact with the ANSM and CPP.

– A model certificate is provided in appendix 6 of the notice to the Sponsor.

7. About site suitability certificate:

– Sponsor must provide a certificate of suitability of the site; the suitability of the investigation site(s) and personnel should be verified before starting the trial.

– The model certificate of suitability must be inserted in appendix 7 of the notice to the Sponsor Model of the certificate of aptitude for the site and the medical team.

8. About File Naming:

– The naming rules are available in appendix 1 of the notice to sponsors for medical device as well as on the CNRIPH website.

9. About GDPR conformity:

– The declaration of conformity with GDPR is imperative it must relate to a reference methodology established in 2016 or later.

– Sponsors must also provide PMCF (Post Market Clinical Follow-up) they may come under MR04.

– If not under MR04, the ethics and scientific comity must be contacted (CESREES).