What clinical evidence does EU MDR require for Class III cardiovascular devices?
Under Article 61(4), clinical investigations are generally required for implantable and Class III devices, subject to the specific exceptions set out in the MDR. Clinical evaluation and PMCF are addressed under Annex XIV, while clinical investigations conducted for conformity-assessment purposes are governed by Article 62 and Annex XV.
Do you support transcatheter valve programmes with VARC-3, MVARC and TVARC endpoints?
Yes. Eclevar supports VARC-3 endpoint architecture for TAVR, and MVARC and TVARC endpoints for TMVR and TTVR respectively, with transcatheter heart valve biometrics, haemodynamic data structures, and coordination of imaging review and clinical-event assessment where required by the study design. VARC-3 is specific to TAVR and is not a generic transcatheter framework: endpoints for LAAO, heart failure and other transcatheter devices are defined device by device.
Can off-label practice or investigator-initiated data support indication expansion?
Potentially, but such data do not automatically support an indication expansion. The scientific question, intended purpose, ethical and legal framework, study design, data quality and regulatory strategy must be assessed together. We design investigator-initiated studies that convert off-label clinical practice into ethical, auditable evidence, structured so the data feeds directly into future PMCF analyses and regulatory submissions.
Which European countries can you run cardiovascular studies in?
We assess country selection during feasibility, covering centre density, device adoption, contracting timelines, cost per patient and the national data assets available for post-market evidence. Europe holds some of the strongest publicly managed cardiovascular data sources in the world: the SNDS and PMSI datasets in France, the DGTHG heart surgery report and the pacemaker and defibrillator register in Germany, NICOR and the National Cardiac Audit Programme in the United Kingdom, RIPI and RIVAC in Italy, the national pacemaker and ICD registries in Spain, and SWEDEHEART and the Nordic device registries linked through personal identification numbers. We use these sources for PMCF design and for reimbursement evidence. Coverage types differ by market; the delivery map above sets out Eclevar's operating model and national data assets for each featured market.
Is a PMCF study always required, or can literature suffice?
PMCF is a continuous process that updates the clinical evaluation. The PMCF plan should justify the combination of general methods, such as literature, user feedback and clinical experience, and specific methods, such as registries or PMCF studies. Whether literature is sufficient depends on the device, its claims, risks and remaining evidence gaps.
How does ISO 14155:2026 change cardiovascular clinical investigations?
ISO 14155:2026 should be applied according to the regulatory, contractual, national and ethics requirements governing each investigation. Eclevar is aligning its study templates and procedures with the 2026 edition.
Who at Eclevar is accountable for my programme?
The people named on this page. Clinical and regulatory strategy is led by Dr Mark Da Costa; European operations by Susanne Höfer and the country delivery leads; data and biometrics by Sébastien Meier Piantanida and Mathilde Renier; medical writing by Pierre-Marie Boutanquoi.
How do we start?
Send your device type, development stage and target countries to the cardiovascular team through the contact page, or email clientcare@eclevar.com. You receive an initial view of the principal clinical, operational and regulatory workstreams for your programme.
United KingdomScott Roe
France & United KingdomCharline Petitdemange
ItalyTeresa Cosentino
