First-in-Human Medical Device Trials in France

France had the most early-stage device studies of any country outside the United States in our data, and more explicit first-in-human work than any other European country we profiled. This guide explains how a first-in-human (FIH) or early feasibility study (EFS) is authorized there, what the registry shows, and when Latin America is the better first step for a United States (US) sponsor.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 141 early-stage, industry-sponsored device studies with at least one site in France, first posted between 1 January 2021 and 28 September 2026. That ranks France #2 worldwide on this measure. Of these, 47 used FIH, feasibility or pilot language in the title or summary, and 17 explicitly described a first-in-human or early feasibility study. 47 were run by sponsors headquartered outside France, 16 of them by US-headquartered companies, and 32 also listed sites in another country. Registrations went from 92 in 2021–2023 to 49 from January 2024 to September 2026.

Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

How authorization works in France

France applies the European Union (EU) Medical Device Regulation (MDR, Regulation (EU) 2017/745). Since 26 May 2021, the French Jardé law framework has not governed MDR device investigations. Two bodies review each study:

• The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM), which receives the dossier by email.
• A Committee for the Protection of Persons (Comité de protection des personnes, CPP), the ethics committee. The CPP is assigned at random through the national SIRIPH2G platform.

Process: the sponsor first gets an IDRCB number (the national identifier ANSM assigns to each study) and then submits to ANSM and the CPP on the same day. ANSM coordinates a 10-day validation, followed by a 45-day evaluation, extendable by 20 days if experts are consulted. According to ANSM’s procedures, silence from ANSM counts as authorization, while silence from the CPP counts as refusal. Sponsors based outside the EU need an EU legal representative (Art. 62(2) MDR).

Where France is strong

• Volume and FIH experience: 141 early studies and 17 explicitly FIH or EFS, the most of any European country we profiled.
• A domestic innovation base: 92 studies were sponsored by French-headquartered companies.
• A parallel review: ANSM and the CPP review at the same time from a same-day submission.
• Clinical range: Cardiovascular (32 studies), ear, nose and throat and hearing (17) and orthopedic and spine (16) led the mix.

Registrations did fall from 92 in 2021–2023 to 49 in 2024–2026. Part of that is registration lag, but the drop was larger than in most countries.

Using data from France in a US submission

The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

How Latin America compares

France runs the ethics and regulatory reviews in parallel, and Paris is six hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

• Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
• Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
• Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
• Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
• Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

When France is the better fit: if your innovation partners or key opinion leaders are French, if you want EU data under the MDR early, or if your technology fits the strong French ear, nose and throat (ENT) and orthopedic base. US teams that want to attend the first cases in a US-aligned time zone should compare a Latin American option.

Frequently asked questions

How long does ANSM take to review a first-in-human device study?

After a 10-day validation, ANSM has 45 days to evaluate, extendable by 20 days if experts are consulted. The CPP ethics review runs in parallel from a same-day submission.

What happens if ANSM or the CPP does not respond in time?

ANSM’s procedures say ANSM silence counts as authorization, while CPP silence counts as refusal.

Does the Jardé law apply to device investigations in France?

Not to investigations under the MDR since 26 May 2021, according to the CPP Sud-Méditerranée II guidance. An IDRCB number is still required.

Can data from a French first-in-human study support an FDA submission?

Yes, if the study meets 21 CFR 812.28 and FDA can validate the data. That makes the data reviewable. It is not clearance or approval.

Next step

Weighing France against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

Sources

• ANSM, Practical procedures for MDR clinical investigations (2022, PDF)
• ANSM, Annex 1: classification and evaluation process for clinical investigations (Jan 2025, PDF)
• ANSM, Request authorisation for a clinical investigation (devices, category 1)
• CPP Sud-Méditerranée II, Submission of files (RIPH)
• Regulation (EU) 2017/745 (MDR), Articles 62 and 70
• 21 CFR 812.28, Acceptance of data from clinical investigations conducted outside the United States (eCFR)
• FDA, Acceptance of Data from Clinical Investigations for Medical Devices
• FDA Recognized Consensus Standards database, ISO 14155:2020 (recognition no. 2-282)
• FDA, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• ClinicalTrials.gov API v2 (query run 28 Sep 2026; filter in Method note)