Eclevar MedTech designs and delivers EU MDR clinical investigations and PMCF studies in Spain. AEMPS submissions, CEIm ethics coordination, in-country monitoring and inspection-ready data, handled end to end from protocol v1.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar to run EU MDR studies in Spain and across Europe. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that builds your EU MDR evidence the way a Notified Body will read it. For Spain that means AEMPS and CEIm dossiers prepared in-house, a clinical evaluation and PMCF programme aligned to Annex XV, and in-country CRAs rather than outsourced monitoring, across 7 countries. Explore our MDR technical review services and our ISO 13485 quality management.
Running a clinical investigation in Spain means clearing two bodies in parallel. We prepare and manage both submissions ourselves, aligned to your EU MDR regulatory strategy.
Clinical investigation (CIV) and PMCF pathways prepared for AEMPS, with EUDAMED registration and Annex XV compliance handled end to end from protocol v1.
Full dossier preparation and management of submissions to Spanish accredited research ethics committees, with single-CEIm coordination for multi-site studies to reduce timelines.
Site qualification across leading Spanish academic hospitals and in-country CRA monitoring under ISO 14155:2026, on-site and remote, with native-language source data review.
AEMPS is Spain's national competent authority, assessing the clinical investigation application under EU MDR Annex XV. A CEIm gives the mandatory ethics opinion. Following the 2023 reform, a single CEIm can cover a multi-centre study, which shortens set-up. We build the dossier so both reviews move together, supported by our feasibility and site selection work and on-the-ground clinical monitoring.
Generalist CROs adapt pharma-first processes to devices after the fact. We design device evidence the way a Notified Body reads it, with the Clinical Evaluation Report and PMCF built as one programme.
Deep clinical and regulatory knowledge in the areas where MDR evidence is hardest, including cardiovascular strategy and orthopaedics and spine.
Clinical strategy and investigations for high-risk cardiovascular and structural heart devices.
Survivorship and outcomes studies for orthopaedic and spinal implants.
Evidence design for active implantable and neurostimulation devices.
PMCF and clinical evaluation for wound management technologies.
Clinical evaluation and post-market evidence for dental technologies.
MILO Studio models your Spanish scope live, tuning 45+ study parameters with your team in one workshop.
Model the study live in MILO Studio and return a three-scenario budget within 48 hours.
Build the CIV protocol and Annex XV dossier from protocol v1.
Submit to AEMPS and coordinate single-CEIm ethics review.
Qualify Spanish hospitals and monitor with in-country CRAs.
PMCF, vigilance and inspection-ready data kept current.
Two bodies govern the pathway. AEMPS, the Spanish Agency of Medicines and Medical Devices, is the national competent authority that reviews clinical investigation applications under EU MDR Annex XV. A CEIm, an accredited research ethics committee, provides the mandatory ethics opinion. Studies are registered in EUDAMED. Eclevar prepares and manages both submissions in-house.
AEMPS is the national competent authority that assesses the clinical investigation dossier and its scientific and regulatory validity under Annex XV. A CEIm is an accredited ethics committee that reviews the ethical acceptability of the study. Since the 2023 reform, a single CEIm can cover a multi-centre study, which reduces timelines. Eclevar coordinates single-CEIm submissions for multi-site trials.
Using the MILO Studio forecasting platform, Eclevar models your Spanish study scope live in a workshop and returns an itemised three-scenario budget, with P25, P50 and P75 recruitment forecasts, within 48 hours. Spanish site fees come from a live hospital tariff database and AEMPS and CEIm submission costs are itemised line by line.
Yes. Spain typically runs alongside France, Germany and the UK in pan-European investigations with a harmonised protocol. Eclevar deploys in-house CRAs across 7 countries, so submissions and monitoring stay consistent across every site.
Yes. Eclevar qualifies sites across leading Spanish academic hospitals and monitors them with in-country CRAs under ISO 14155:2026, on-site and remote, with native-language source data review rather than outsourced monitoring.
Talk to our team about your device, your AEMPS and CEIm route and how a single evidence base can serve Spain and the wider EU.
Book a free scoping call