France • Woundcare • Clinical Evidence
France is one of the most attractive settings in Europe for generating woundcare clinical evidence. It combines deep clinical expertise with an experienced network of investigators and sits within one of the largest medical technology markets in Europe. Public sources note that France's medtech market is one of the top five markets in Europe and French Healthcare describes France as Europe's secondlargest medical technologies market, behind Germany. Evidence generated in France can be shaped to serve multiple goals, including MDR clinical evidence, postmarket clinical followup (PMCF), early adoption studies and reimbursement discussions when planned with the end decision in mind.
The step that many nonFrench teams underestimate is that the Comité de Protection des Personnes (CPP) is not the only authority involved in a device investigation. In France, research involving human participants is governed by the Jardé law, which classifies research into three categories.
Studies are interventional and involve a risk to participants; they require both authorisation from the French National Agency for Medicines and Health Products Safety (ANSM) and a favourable opinion from a CPP.
Studies are interventional with minimal risks or constraints and require a favourable CPP opinion but no ANSM authorisation.
Studies are noninterventional (observational) and require a CPP opinion but no ANSM involvement.
The Jardé categories do not mirror MDR classifications exactly; determining the correct category at the planning stage is essential because it dictates whether you will submit your dossier to ANSM in addition to the CPP.
ANSM publishes a detailed list of documents that must be provided for a clinical investigation dossier. These requirements apply to device investigations under the Medical Device Regulation (MDR) and performance studies for IVDs. An official annex summarises which documents are mandatory, which are conditional and which must be in French. Key items include:
These documents must specify version and date. A summary of the plan in French is also required.
The investigator brochure must contain all elements required under Annex XV of the MDR and list compliance with general safety and performance requirements; if it belongs to a third party, written permission is required.
Sponsors must provide a signed statement that the investigational device meets applicable safety and performance requirements, except for aspects being investigated.
Proof of insurance covering participants for injury must meet the requirements of the French Public Health Code (Articles L112110 and R11214 to R11219). The coverage must span from first inclusion to the last visit and include the estimated end date and EU legal representative's details.
Use our practical self-check to validate dossier completeness, translations, version control, and the official naming convention before submission.
All participantfacing materials including information sheets, consent forms and recruitment adverts must be submitted and translated into French.
Sponsors must describe how personal data will be protected and kept confidential.
The annex also highlights that file names and version numbers must follow the prescribed naming convention and that any document marked "FR" must be submitted in French. Preparing these materials correctly at the outset prevents delays caused by completeness checks.
Based on recent submissions and past projects in wound care, we see common patterns in CPP/ANSM interactions: Your dossier may be reviewed by a committee member who specialises in medical devices or one who mainly evaluates medicinal product trials. Variability in reviewer background means your narrative must be clear
Provide a brief cover letter or introduction that explains the medical context, the device's intended use and what the study will and will not do. Clarify the Jardé category and whether ANSM authorisation is required. Outline how participants are protected and why the study is scientifically justified.
Check early whether your study is Category 1, 2 or 3 and document your rationale. Category 1 studies require ANSM authorisation and a CPP opinion, while categories 2 and 3 require only CPP review. The classification may differ from MDR study types, so seek local advice if unsure.
The number of documents can feel overwhelming. A structured checklist ensures that mandatory documents for example, the FAIC, clinical investigation plan, investigator brochure, insurance certificate, translations and dataprotection description, are included and correctly named. See our downloadable CPP/ANSM readiness checklist for a practical selfcheck.
Because allocation to CPPs is random, assume that your reviewers may not be woundcare specialists. Provide plainlanguage explanations of wound healing, endpoints and device mechanisms. Use diagrams or flow charts to illustrate participant pathways.
Allocate internal owners for potential CPP and ANSM questions. Prepare templates for responses and establish a process for quick document updates. Responding promptly and consistently is critical to avoid extended review cycles.
Eclevar MedTech is a Francebased contract research organization specialising in woundcare clinical evidence. We help manufacturers from strategic planning through to submissions and study delivery. Our support includes:
We help you align study design with your goal, whether MDR evidence, PMCF, adoption or reimbursement, and determine the correct Jardé category.
We compile CPP/ANSM submission packages, ensuring documents follow the official naming convention and are translated where required. Our medical writers produce plainFrench participant materials and cover letters.
We leverage a wide network of woundcare investigators across France and provide operational support from first contact to data collection. We are supported by Prof Luc Téot as a clinical advisor and have extensive relationships with key opinion leaders (KOLs) nationwide.
If you are attending Journées Cicatrisations next week in Paris, we would be happy to discuss your French evidence plan. You can book a short meeting with us via our website. The form collects your product category, objective (MDR evidence, PMCF, reimbursement or adoption), target timeline and preferred time of day. After you submit the form, we will reply by email with suggested times and a short agenda.
The people who build your evidence have sat on the other side of the table.
Whitepapers and publications produced by our teams with our notified body partners.
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, the same evidence your file has to support.
The services and topics connected to this page.
Send us the device, the claim and the deadline. You get a written answer within 24 hours.
Your documents are reviewed confidentially. An NDA can be signed before we receive any technical or clinical information.
Dr Mark Da Costa
Dr Nikhil Khadabadi
Pierre-Marie Boutanquoi