US Sponsors / European Clinical Delivery
Design and deliver your first-in-human, feasibility, or pivotal study in Europe while keeping the intended FDA evidence pathway in view.
Running medical device clinical trials in Europe is a strategic choice, not a cost decision. Eclevar helps US sponsors determine whether a US-only, Europe-led, or hybrid model answers their clinical and regulatory question, then delivers the European component under one specialist program governance, from strategy and protocol through sites, data, and reporting.
Experience across cardiovascular, orthopedics, neuromodulation, wound care, and continence care.
The decision before the country
The question is not whether Europe is less expensive, but which geography and study model can answer the question your program has to close. Eclevar assesses all three options before recommending a delivery model. If Europe does not provide a defensible evidence or operating advantage, the recommendation should say so.
Study model decision architecture
Four shared evidence domains, three candidate models, one decision.
Regulatory use
FDA may accept clinical data from investigations conducted outside the United States when the applicable requirements are met, including the conditions set out in 21 CFR 812.28 for investigations supporting an IDE or device marketing application. These include well-designed and well-conducted research, good clinical practice, independent ethics committee review, informed consent, supporting documentation, and FDA's ability to validate the data. Separately, the relevance of the population, clinical practice, device configuration, endpoints, and resulting evidence to the intended US use should be assessed for the planned submission.
European clinical data may support an FDA submission when the study is designed, conducted and documented for its intended regulatory use. Final acceptability remains subject to FDA review. Conformity with good clinical practice or with ISO 14155 does not by itself make data acceptable to FDA.
If the European data are intended to support a material FDA decision, the sponsor should assess whether FDA feedback is appropriate before pivotal protocol lock. Early FDA feedback may identify material concerns while the protocol and operating model can still be revised with less disruption. A detailed reading of the requirements is covered in Can European Clinical Data Support an FDA Medical Device Submission?
Evidence architecture
The clinical question, population, endpoints, data generation, and analysis may be planned within a shared evidence architecture where the intended regulatory uses are aligned prospectively. Jurisdiction-specific requirements, analyses, documentation, or additional evidence may still be required, and one study does not automatically satisfy both pathways.
One study architecture, two regulatory uses
Five shared layers, two jurisdiction-specific evidence uses.
Delivery
Four workstreams under one program governance.
We start from the claim your program has to support and work backward to the study that can support it, including the choice of model and the intended regulatory uses of the dataset.
Eclevar manages the European regulatory and ethics submission workstream under one program governance, using verified local processes and support where required.
Monitoring is planned around the data that carry the primary question, combining on-site and remote work with centralized review. Safety and device deficiency handling runs as a defined process with traceable timelines, under one accountable team.
The people who build the database work inside the same program governance as the teams running the sites. Statistical methods are agreed before lock, and the report is written by the team that followed the program.
Related capabilities: feasibility and site selection, study start-up, clinical monitoring, clinical data management, and regulatory affairs and strategy.
Country strategy
Eclevar builds the country and site model from the indication, procedure, protocol-eligible population, investigator capability, standard of care, infrastructure, and intended evidence use. The output is a small set of countries and named sites with a documented recruitment basis. No approval timeline is published here: timelines depend on the country, the classification, and the dossier.
Country and site selection framework
Proof
Pre-market clinical investigation, completed
Coloplast A/S sponsored a pre-market clinical investigation of an investigational compact intermittent catheter for female users. The question: whether the device could be assessed against CE-marked comparators under real conditions of use, including home use, with objective and participant-reported measures collected consistently across countries.
A multicenter, randomized, open-label, crossover design, publicly registered as NCT05814211. Sequence, timing, and assessment windows had to be identical at every site across three countries with different submission and contracting routes, with part of the data generated at home and participant burden treated as a design constraint.
Eclevar's contribution covered clinical evidence architecture, European delivery, and statistical methodology, within the scope contracted by the sponsor and alongside the sponsor's own responsibilities.
This was a European pre-market clinical investigation, not a US sponsor program or an FDA Early Feasibility Study. It is presented to demonstrate relevant multicountry European delivery capability, not FDA acceptance or sponsor endorsement. Study facts are taken from the public registration; outcomes and comparator identities are not published here.
Accountability
Therapeutic authority sits with the people responsible for delivery. Our physician leadership includes former Notified Body clinical reviewers. Therapeutic practices: cardiovascular and structural heart, orthopedics and spine, neuromodulation and neuro-implants, advanced wound care.
Cardiovascular and structural heart
Chief Operating Officer and Head of Cardiovascular, Senior Consultant Surgeon
Mark leads cardiovascular clinical strategy, combining 25 years of Consultant Cardiac Surgery experience with first-hand senior leadership Notified Body experience. On this pathway he tests whether the proposed model, population, and endpoints will withstand clinical and regulatory scrutiny, including procedural learning, imaging, and event adjudication in structural heart programs.
Orthopedics, spine, and surgical robotics
Chief Medical Officer, Orthopedics and Spine
Orthopedic surgeon and former Notified Body senior reviewer. He works on programs where operator learning, investigator qualification, and implant, imaging, and procedural evidence determine the study design, and on how those factors are handled when sites sit in more than one country.
US clinical-operations perspective
Strategic Clinical Advisor, US Clinical Operations
Dawn provides strategic input on US clinical operations, helping test whether the proposed European operating model is practical for a US sponsor and remains connected to US site, sponsor, and delivery expectations. She works with Eclevar's central clinical, medical, data, and project leadership as an external strategic advisor.
European clinical delivery
Head of Clinical Operations, DACH region · Project Delivery Lead, France and United Kingdom
Susanne assesses whether the proposed site model is deliverable and what it takes at site level. Charline owns program accountability: submissions, activation, contracting, and the day-to-day operation that turns an agreed model into open sites and enrolled participants.
Data, statistics, protocol, and reporting
Chief Data Officer · Head of Medical Writing
Sébastien defines the data standard and the analysis approach that has to hold across regions and survive scrutiny of the conduct. Pierre-Marie leads protocol and clinical investigation report writing, drafted by the team that followed the study.
Full leadership
Roles, backgrounds, and how senior oversight works across programs.
The next step
Resolve the highest-impact assumptions before the pivotal budget is committed.
Uncertainty and cost of change across the program
Illustrative only. No units, and not derived from a clinical or financial dataset.
No confidential documentation is required to start.
An informed recommendation, not a regulatory conclusion.
Official content
Whitepapers, client voices and publications produced by our own teams and by our partners: BSI, TÜV SÜD and RegenLab.
Whitepaper · BSI x Eclevar
Written with the notified body BSI: a practical look at what clinical evidence has to show under EU MDR 2017/745, and at the quality bar the data have to clear. It is the same bar a European dataset meets before it is put in front of any reviewer.
PMCF studies · Regenerative medicine · 5 EU countries
Eclevar runs RegenLab's PMCF program on chronic wound products. It is a randomized study of 160 subjects across 14 centers in 5 EU countries, covering both diabetic foot ulcer and venous leg ulcer. The partnership combines Eclevar's ISO 14155 expertise with the Milo Studio platform, from study design through to the final study report.
« Eclevar, with its tailored approach and the advanced Milo Studio platform, represents a significant strategic advantage. »Antoine Turzi, CEO, RegenLab
Coming soon. Breakthrough Device Technology under the EU MDR, a whitepaper written with TÜV SÜD, co-authored by Dr Nikhil Khadabadi.
Questions we are asked first
FDA may accept data from clinical investigations conducted outside the United States when the investigation is well designed and well conducted and the conditions in 21 CFR 812.28 are met, including conduct in accordance with good clinical practice and provision of the supporting information the regulation describes. Acceptability of any specific dataset remains subject to FDA review.
Yes. A US medical device company may conduct first clinical use or another clinical investigation in Europe, subject to the applicable European and national requirements. If the data are later intended to support an FDA submission, the applicable FDA requirements should shape the design and documentation from the start rather than be reconstructed afterward.
Typically when US representation matters for the question, but part of the recruitment or early clinical experience can be resolved in Europe. Regional differences may introduce heterogeneity or treatment-effect modification that should be anticipated in the design and analysis, so the pooling strategy, harmonized procedures, and a single data standard are defined before enrollment.
From the protocol. Population and severity mix, procedure volume, investigator caseload, standard of care, infrastructure, submission route, follow-up burden, and device logistics vary by country and indication. The credible output is a small set of countries and named sites with a documented recruitment basis.
Sometimes, and it should be assessed rather than assumed. The clinical question, population, endpoints, data generation, and analysis may be planned within a shared evidence architecture where the intended regulatory uses are aligned prospectively. Jurisdiction-specific requirements, analyses, documentation, or additional evidence may still be required, and one study does not automatically satisfy both pathways.
Study route assessment, evidence strategy and protocol, country and site feasibility, the European regulatory and ethics submission workstream, contracting and activation, investigator training, monitoring, safety and device deficiency oversight, clinical data management, biostatistics, and the clinical investigation report, under one program governance.
The next conversation is about your device, your intended use, and the decision you are trying to close.
