France is one of Europe's most demanding IVD markets, and the difference between a 90-day and a 9-month start-up is knowing the ANSM, the CPP and Loi Jardé from the inside. Eclevar delivers IVDR 2017/746 clinical performance studies end to end, with in-house CRAs resident in France and Eclevar Healthtech SAS able to act as your French legal sponsor.
Paris HQ · CRAs resident in France
One accountable Paris-based team runs your regulatory strategy, ethics dossier, French site network and data management, on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Diagnostic and device leaders across oncology, infectious disease and self-testing choose Eclevar. Read all client success stories.
An IVD performance study generates the scientific validity, analytical performance and clinical performance evidence that IVDR 2017/746 requires before an in-vitro diagnostic can be CE-marked, and in France that evidence has to pass through a specific national governance framework.
Under IVDR 2017/746, IVD manufacturers must demonstrate performance through a structured performance evaluation, and higher-risk studies fall under Article 58. In France these studies sit inside the Loi Jardé research framework: every study is reviewed by a randomly assigned Comité de Protection des Personnes (CPP), and interventional or Article 58 studies also require authorisation from the ANSM, France's competent authority. Submissions and amendments run through the national SIRIPH portal, and data handling must align with the relevant CNIL référentiels (MR-002, MR-003).
The classification of the study under Loi Jardé (categories 1 to 3) decides which pathway applies, how residual specimens can be used, and whether ANSM authorisation is needed alongside the CPP opinion. Getting that classification right the first time is the single biggest lever on your timeline. This is the core of our IVD clinical research CRO service, applied to the specifics of the French market.
Eclevar delivers the study as one connected service, from feasibility and site selection across French CHUs and reference labs through study initiation, monitoring and the data management that feeds your Performance Evaluation Report.
Eclevar's model brings the regulatory perspective inside the CRO, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark Da Costa, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO and also a former TÜV SÜD senior reviewer, lead a team that designs performance evidence exactly the way Notified Bodies and competent authorities expect to read it, from the first protocol version.
Who classifies, submits and initiates your study, and how well they know the French system, decides whether you start in 90 days or lose a quarter to avoidable queries. The gap is structural.
Every step of a French IVDR performance study, from Loi Jardé classification through ANSM and CPP submission to database lock and reporting, run in-house with full traceability.
Loi Jardé category assessment and IVDR Article 58 analysis that decide whether you need ANSM authorisation alongside the CPP opinion, and how residual specimens can be used.
Authorisation strategy and full regulatory affairs support: dossier build, SIRIPH portal management and statutory communications with the authority.
Comité de Protection des Personnes dossier preparation and submission, with CNIL référentiel alignment (MR-002 / MR-003) for data-protection compliance.
Site selection across French university hospitals (CHU) and reference labs, then study start-up with CRAs resident in France.
On-site and remote, risk-based monitoring, plus clinical data management on MILO Studio, EU-hosted and CNIL-aligned.
Statistical analysis plans, sample-size justification, sensitivity, specificity and AUC endpoints, and Performance Evaluation Report chapter authorship, under our ISO 13485 quality system.
One accountable team covers every stage of the performance study lifecycle, so nothing is lost between a protocol, a CPP submission and a Performance Evaluation Report.
IVDR performance studies under ISO 20916, from feasibility and site selection and study initiation through French ethics submissions and monitoring.
Regulatory affairs and strategy: ANSM authorisation, CPP dossiers, Loi Jardé classification and SIRIPH portal management for the French pathway.
100% in-house clinical data management and EDC: eCRF design, database lock and ALCOA+ inspection-readiness, powered by MILO Studio, EU-hosted and CNIL-aligned.
Statistical analysis plans, sample-size justification and diagnostic endpoints (sensitivity, specificity, AUC, 2×2 confusion matrix) built natively into the performance study design.
Long-term real world evidence and post-market performance follow-up to keep IVDR performance evaluation current after CE marking.
Acting as your French legal sponsor or co-sponsor, so a manufacturer never has to set up a separate French entity to run a study, all under an ISO 13485 quality system.
A manufacturer of a Class C oncology companion diagnostic needed French clinical performance evidence but had no local entity and an uncertain Loi Jardé classification. Eclevar classified the study up front, confirmed it required both ANSM authorisation and a CPP opinion, and prepared parallel submissions through the SIRIPH portal with CNIL référentiel alignment built in.
Eclevar Healthtech SAS acted as French sponsor, CRAs resident in France ran same-week site initiation across CHU sites and reference labs, and MILO Studio captured the sensitivity, specificity and comparator-method endpoints natively, feeding a clean, traceable dataset for the Performance Evaluation Report.
Outcome: a first-time-right dossier, parallel ANSM and CPP review, and an inspection-ready evidence trail, instead of a start-up stalled on classification queries.
Paris HQ, CRAs resident in France and Eclevar Healthtech SAS as legal sponsor. France is a home market, not a distant one.
Former TÜV SÜD reviewers who know how performance evidence is assessed, designing it right from protocol v1.
Proprietary EDC built for IVDR Annex XIII: 2×2 endpoints, comparator capture and specimen chain-of-custody, native not bolted-on.
In-house regulatory writers who build ANSM and CPP dossiers on the SIRIPH portal and speak the classification language.
Platinum Award winner, EUCROF 2026, ranked first for clinical validation, data interoperability and patient-centred design.
ISO 13485 certified, CNIL-aligned, EU-hosted data. Every study structured for ANSM inspection readiness with live ALCOA+ scoring.
France is delivered from the ground up, and the same in-house model of employed CRAs and project leads, not subcontractors, extends across the EU, the UK and Japan corridors.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical and performance evidence expectations under the EU regulatory framework, relevant to any high-risk device or diagnostic program.
Eclevar manages RegenLab's PMCF program on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
An IVD clinical performance study demonstrates that a diagnostic delivers the scientific validity, analytical performance and clinical performance required by IVDR 2017/746. In France these studies are governed by the Loi Jardé framework, require review by a Comité de Protection des Personnes (CPP), and where interventional or falling under Article 58 also require authorisation from the ANSM.
It depends on the study category under Loi Jardé and IVDR Article 58. Interventional performance studies typically require both ANSM authorisation and a favourable CPP opinion, submitted in parallel. Studies using genuinely residual specimens with no additional sampling may follow a lighter Loi Jardé pathway that is still reviewed by a CPP. Eclevar classifies each study up front to route it correctly.
CPP review runs a median of 45 to 60 days and an ANSM assessment around 60 days, and the two can proceed in parallel. A realistic timeline is 90 to 120 days from protocol lock to first-patient-in, provided the dossier, SIRIPH submission and CNIL référentiel alignment are prepared correctly the first time.
Yes, when the specimens are genuinely residual, involve no additional venipuncture or intervention, and are used with appropriate consent under the correct Loi Jardé category. This route can shorten timelines significantly, but it still requires CPP review and correct documentation, which Eclevar prepares and submits.
SIRIPH is the French national electronic portal used to submit research notifications, dossiers and amendments and to handle statutory communications with the authorities. Eclevar manages the portal account, builds and submits the dossier, and handles the regulatory correspondence on the sponsor's behalf.
Yes. Eclevar Healthtech SAS is a registered French legal entity and can act as sponsor or co-sponsor for your performance study, removing the need for a manufacturer to set up its own French entity to run a study on French sites.
Generalist CROs treat France as one of many EU markets and lose time on ANSM expectations, CPP dossier nuance and Loi Jardé classification. A France-specialist IVD CRO with in-house regulatory writers, CRAs resident in France and an established CHU network can classify, submit and initiate faster, with a single accountable team and no sub-CRO subcontracting.
Talk to our Paris team about your diagnostic, your Loi Jardé classification and a route through ANSM and the CPP built for a 90-day start.
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