Registry evidence built the way notified bodies expect to read it. Eclevar designs and runs cardiovascular device registries across Europe, from protocol and endpoint architecture through national database integration to the report a reviewer opens. One team, physician led, in house from first patient to final PMCF report.
The people who build your evidence have sat on the other side of the table.
Dr Mark Da CostaChief Operating Officer and Head of CardiovascularFormer TÜV SÜD Team Leader
Sebastien Meier PiantanidaChief Data OfficerData management and EDC
Charline PetitdemangeProject Delivery Lead, France and United KingdomStudy start-up and close-out
Registry evidence built the way notified bodies expect to read it. Eclevar designs and runs cardiovascular device registries across Europe, from protocol and endpoint architecture through national database integration to the report a reviewer opens. One team, physician led, in house from first patient to final PMCF report.
Leading manufacturers rely on Eclevar for registry-based PMCF and real-world evidence. Read all the client success stories.
Cardiovascular registries have to account for a wide mix of patients, hospitals, operator skill levels, learning curves and device iterations. A generic observational template does not survive contact with that, and it shows in the dataset two years later.
Our cardiovascular endpoints are designed by clinicians who understand the procedure and the expected clinical course, then checked against the questions assessors actually ask. That combination, a consultant cardiac surgeon of 25 years who has also sat on the reviewing side, is what the registry file is built on.
A cardiovascular device registry is a prospective or retrospective observational data collection system that tracks how a device performs in routine clinical practice, across many sites, operators and patients, over years rather than months. It produces real-world evidence of safety and performance across the expected lifetime of the device.
Unlike a randomized pivotal trial, a registry is not built to prove a hypothesis before market access. It generates the continuous evidence the EU MDR requires a manufacturer to hold for as long as the device stays on the market, accounting for a varied mix of patients, hospitals, operator skill levels, surgical learning curves, device iterations and procedural variability that a fixed trial protocol cannot reach. Where the two methods diverge, and how to choose, is set out in registry versus clinical investigation.
Under EU MDR 2017/745, for implantable and Class III cardiovascular devices, Annex XIV Part B and MDCG 2020-7 treat registry-based post-market clinical follow-up as a core method for demonstrating continued safety, performance and clinical benefit over the expected lifetime of the device. The route conditions are on our PMCF registry CRO page.
A registry built for one of these and read for another is where most disappointment comes from. The intended use decides the endpoints, and the endpoints decide everything downstream.
The primary use case for cardiovascular registries, feeding the clinical evaluation report on every cycle rather than at the end of a program.
Long-term outcome data supporting national market access alongside the CE mark, which matters particularly in France and Germany. See CNEDiMTS and G-BA pathways.
Tracking outcomes across device generations or competing platforms inside one harmonized model, so the comparison is designed rather than reconstructed.
Converting established clinical practice into structured, auditable data that can carry an argument rather than an impression.
Closing evidence gaps flagged during the MDR transition for legacy devices, or raised during review of a new device.
This page covers cardiovascular device registries. Broader cardiovascular clinical strategy, including pre-market work and core lab services, is on structural heart and cardiovascular device CRO, and PMCF study execution on cardiovascular PMCF and follow-up studies.
Nothing is lost between protocol design, site delivery and the report a notified body will read.
Protocol, objectives and endpoint selection mapped to the General Safety and Performance Requirements, including VARC-3 for TAVR and MVARC and TVARC for TMVR and TTVR, built the way reviewers expect to see it from version one.
Market selection weighed against cardiovascular center density, investigator experience, contracting timelines, and critically which national databases already hold part of the answer. Method on registry feasibility and site selection.
Registry endpoints aligned with existing national cardiovascular data assets and with the broader EUDAMED post-market strategy, so you are not building duplicate infrastructure.
eCRF design, validation and cohort build on our proprietary EDC and data management platform, built natively for EU MDR work and compliant with 21 CFR Part 11, ICH-GCP, GDPR and HL7 FHIR and OMOP CDM.
On-staff clinical research associates rather than subcontractors, across seven countries, handling site initiation, ethics submissions and source data verification to ISO 14155:2026. Site coordination stays under direct Eclevar control. See on-site and remote monitoring.
Biometrics, safety signal review and long-term outcome analysis, delivered as PMCF evaluation reports and clinical evaluation report updates ready for notified body submission.
VARC-3, MVARC and TVARC endpoint architecture, with transcatheter valve biometrics and hemodynamic data structures. Related work on TAVI clinical studies.
Coronary artery disease and drug-eluting stent registries under EU MDR clinical scrutiny, including drug-eluting technologies.
Aneurysm repair, peripheral and venous stents, vascular closure and access systems. Class IIb and Class III devices that require specific and rigorous PMCF activity.
Class III rhythm management evidence design, aligned with national pacemaker and ICD registries.
Annuloplasty devices, cardiac patches, thoracic aortic grafts and perfusion systems, designed surgeon led. See MDR compliance for Class III cardiac implants.
Multi-variant registry evidence across broad access-device portfolios, registry evidence for cardiovascular imaging and software classified under the applicable MDR rules, and harmonized observational models across multi-family vascular portfolios.
Europe holds some of the strongest publicly managed cardiovascular data sources in the world. Registry access, coverage type and data governance requirements are confirmed for each program during feasibility.
| Market | Registry or data asset | Relevance |
|---|---|---|
| United Kingdom | NICOR, National Cardiac Audit Programme, Transcatheter Mitral and Tricuspid registry | Cardiac device and procedure data across NHS and private hospitals |
| France | Systeme National des Donnees de Sante and PMSI | National claims and hospital stay data, linkable to device outcomes |
| Germany | German Heart Surgery Report registry (DGTHG), German pacemaker and defibrillator registry | Surgical outcomes and rhythm device tracking |
| Italy | RIPI, the Italian implantable prosthetic registry, and RIVAC, the Italian heart valves registry | National pacemaker and cardiac device registries |
| Spain | Registro Nacional de Marcapasos and the Spanish implantable cardioverter-defibrillator registry | Long-term rhythm device surveillance |
| Nordics | SWEDEHEART, Swedish pacemaker and ICD register, Danish pacemaker and ICD register, Danish Heart Registry, Norwegian pacemaker and ICD registry | Personal identification number linked, decades deep longitudinal data |
Assess data source quality, site access and completeness before committing to a design.
A registry protocol aligned to ISO 14155:2026, GCP and device-specific endpoint frameworks.
Systematic capture from sites, registries and health records through MILO Studio.
Statistical review of safety, performance and long-term outcomes, designed with the endpoints rather than after them.
PMCF evaluation reports and clinical evaluation report updates, delivered inspection ready.
Eclevar designed and delivered six registered retrospective PMCF studies across three device families, vascular patches, surgical vascular prostheses and implantable venous access ports, for a European vascular device manufacturer, using a single harmonized observational evidence model rather than six separate designs.
Endpoints and reports designed by a team led by a former notified body team leader and senior reviewer, who is also a consultant cardiac surgeon of 25 years, built against the questions assessors actually ask.
Clinical operations, data management and medical writing under one roof. No handoff fragmentation, one point of accountability for your registry.
Proprietary EDC built natively for EU MDR registries, with AI-assisted eCRF generation and Annex XIV mapping. Platinum Award winner, EUCROF 2026.
In-house clinical teams across the UK, France, Germany, Italy, Spain and the Nordics, with direct access to the region's strongest cardiovascular data assets.
Registry design informed by procedural reality, accounting for the real mix of patients, hospitals, operator skill levels, learning curves and device iterations.
ISO 13485 certified processes and trial master file completeness structured for notified body inspection from the first patient enrolled, inside our quality management system.
Whitepapers, client voices and publications produced by our teams and our partners (BSI, TÜV SÜD, RegenLab).
A trial is designed to test a hypothesis under controlled conditions, usually before market access. A registry is an observational system that tracks real-world outcomes across many sites and operators over years, and it is the primary tool the EU MDR expects manufacturers to use for continuous post-market follow-up.
It depends on the device, its claims and its remaining evidence gaps. A PMCF plan should justify a combination of general methods, such as literature and user feedback, and specific methods, such as registries or dedicated PMCF studies. We assess that during feasibility rather than assuming one model fits every device.
Yes. We align registry endpoints with national cardiovascular data assets such as NICOR in the UK, SNDS and PMSI in France, the German pacemaker and defibrillator registry and the German Heart Surgery Report registry, RIPI and RIVAC in Italy, and the Nordic registers including SWEDEHEART, and with the broader EUDAMED strategy, so you are not duplicating infrastructure that already exists.
Structural heart including TAVI, TMVR, TTVR and LAAO, coronary intervention, aortic and peripheral vascular, cardiac rhythm management, cardiac surgery, guidewires and delivery systems, and cardiovascular imaging and software devices, focused on higher-risk Class IIb and Class III devices.
Cardiovascular registries typically run three to ten years depending on device class and follow-up requirements, which are largely driven by the expected lifetime of the device. Cost depends on country count, site number, endpoint complexity and follow-up length. We scope every program to the minimum defensible evidence a notified body will accept, then provide an itemized proposal after a short scoping call. The drivers are set out on registry cost and timeline.
Send us your device type, development stage and target countries. Our cardiovascular team returns an initial view of the clinical, operational and regulatory workstreams for your registry within a scoping call. Contact the cardiovascular team.
A trial is designed to test a hypothesis under controlled conditions, usually before market access. A registry is an observational system that tracks real-world outcomes across many sites and operators over years, and it is the primary tool the EU MDR expects manufacturers to use for continuous post-market follow-up.
It depends on the device, its claims and its remaining evidence gaps. A PMCF plan should justify a combination of general methods, such as literature and user feedback, and specific methods, such as registries or dedicated PMCF studies. We assess that during feasibility rather than assuming one model fits every device.
Yes. We align registry endpoints with national cardiovascular data assets such as NICOR in the UK, SNDS and PMSI in France, the German pacemaker and defibrillator registry and the German Heart Surgery Report registry, RIPI and RIVAC in Italy, and the Nordic registers including SWEDEHEART, and with the broader EUDAMED strategy, so you are not duplicating infrastructure that already exists.
Structural heart including TAVI, TMVR, TTVR and LAAO, coronary intervention, aortic and peripheral vascular, cardiac rhythm management, cardiac surgery, guidewires and delivery systems, and cardiovascular imaging and software devices, focused on higher-risk Class IIb and Class III devices.
Cardiovascular registries typically run three to ten years depending on device class and follow-up requirements, which are largely driven by the expected lifetime of the device. Cost depends on country count, site number, endpoint complexity and follow-up length. We scope every program to the minimum defensible evidence a notified body will accept, then provide an itemized proposal after a short scoping call. The drivers are set out on registry cost and timeline.
Send us your device type, development stage and target countries. Our cardiovascular team returns an initial view of the clinical, operational and regulatory workstreams for your registry within a scoping call. Contact the cardiovascular team.
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.
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