Life Sciences 2025

FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery

Medical Devices For medical devices, clinical trials are manda- tory for Class III and implantable devices (unless exempt). Applications must be submitted electronically to the ANSM, together with the documents referred to in EU law. The new application procedure under the MDR, which mandates submission via the European Database on Medical Devices (EUDAMED) using the Clinical Investigations and Performance Studies Module, is not yet applica- ble as the module remains non-operational. Until its implementation, national procedures remain in effect. Upon submission, the application undergoes a validation review co-ordinated by the ANSM, completed within ten days from the date of receipt. If the application is incomplete, the sponsor is granted ten additional days to pro- vide the missing information. Upon receiving additional documents, the ANSM and the eth- ics committee have five days to review updates and notify the sponsor of validation or rejection. Once validated, the application undergoes a scientific assessment by the ANSM and ethical assessment by the ethics committee, within 30 to 65 days, depending on the category of clinical trial (which is determined primarily based on the purpose and status of the medical device). The final decision is notified to the sponsor. 2.3 Public Availability of the Conduct of Since January 2025, all clinical trials on pharma- ceuticals must be registered in the CTIS. Spon- sors are required to submit trial results within one year of completion, after which the data is published on CTIS. Clinical trial information a Clinical Trial Pharmaceuticals

tion of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial The procedure for securing authorisation to undertake a clinical trial of a pharmaceutical and a medical device is essentially as follows. Pharmaceuticals For pharmaceuticals, applications must be sub- mitted to the ANSM via the Clinical Trials Infor- mation System (CTIS), a centralised EU-wide electronic platform introduced by the CTR, and must include all information listed in EU law. Upon submission to the ANSM, the application undergoes a validation review completed within ten days from the date of receipt. If the applica- tion is incomplete, the sponsor is granted ten additional days to provide the missing informa- tion. Upon receiving additional documents, the ANSM has five days to review updates and notify the sponsor of validation or rejection. Once validated, the application undergoes a scientific assessment by the ANSM and ethical assessment by the competent ethics committee in France, within 45 days. In the event of requests for additional information, the evaluation period is extended by a maximum of 31 days. For mul- tinational trials, the scientific assessment is a joint decision among the health authorities of the involved EU member states. The final decision is notified to the sponsor via CTIS within a maximum of five days following the later date between the scientific assessment report and the ethical assessment report.

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