Eclevar Medtech delivers specialised clinical programs for the most complex Class III AIMDs under EU MDR. From early feasibility and clinical evaluation to long-term PMCF excellence and ePRO-driven follow-up under Annex IX and Annex X.
Spinal Cord Stimulation systems for chronic pain management, including novel waveforms and closed-loop stimulation.
Deep Brain Stimulation systems for Parkinson's disease, essential tremor, dystonia, and emerging psychiatric targets.
Vagus nerve stimulators (VNS), sacral neuromodulation, targeted peripheral nerve implants and TENS.
Cochlear implants, retinal prostheses, and complex neurovascular intervention devices.
Active Implantable Medical Devices (AIMDs) face the highest level of scrutiny under EU MDR. The transition from the old AIMDD to the new MDR framework means Notified Bodies now demand extensive 10-year PMCF follow-ups, precise patient-reported outcome captures, and rigorous justification for off-label or indication expansions.
Neuro implants are expected to perform safely for over a decade. We design 10-year longitudinal PMCF strategies that track battery depletion, lead migration, and long-term device safety without losing patient engagement.
Demonstrating efficacy in neuromodulation relies heavily on subjective patient feedback. We deploy our validated eCOA/ePRO MILO platforms and its integrated telemedicine interface to capture daily pain diaries and Quality of Life metrics reliably.
Many neuromodulation therapies evolve through off-label clinical practice. We structure Investigator-Initiated Studies (IIS) to generate regulator-acceptable evidence for official indication expansion under EU MDR.
Eclevar Medtech utilises a structured and seamless delivery process that connects regulatory strategy, study operations, and complex ePRO data collection into one coordinated evidence pathway.
Evaluating existing clinical data and literature against EU MDR Annex IX and X requirements to identify specific risks.
Designing targeted clinical investigations, longitudinal patient surveys, or registry-based PMCF plans for your active implant.
Deploying validated Electronic Data Capture systems through MILO for secure multi-site data, properly fed pain diaries, and quality of life tracking.
Activating our specialised network of neurosurgeons and pain clinics across key European territories.
Authoring audit-ready Clinical Evaluation Reports (CER) and PMCF evaluation reports for the Notified Body.
From complex Deep Brain Stimulation registries to ePRO-driven Spinal Cord Stimulation surveys, Eclevar Medtech has supported neuro device manufacturers at every stage of the Annex IX and Annex X regulatory lifecycle.
A major neurotechnology manufacturer required a ten-year PMCF strategy for a novel DBS system. Eclevar Medtech designed the PMCF Plan, established the EDC architecture for long-term battery depletion tracking, and integrated the data collection directly with national neurological registries to minimise site burden.
To satisfy Notified Body requirements for subjective efficacy data, Eclevar Medtech deployed a multi-country PMCF survey utilising MILO EDC. The programme automated the collection of daily pain diaries (VAS) and Oswestry Disability Index (ODI) scores directly from patient mobile devices.
Implementation of validated daily pain diaries, Visual Analogue Scales (VAS), Oswestry Disability Index (ODI), and overall Quality of Life metrics (EQ-5D) to demonstrate clear functional improvement over time.
Standardised assessment protocols for disease-specific endpoints. Eclevar Medtech tracks metrics like UPDRS for Parkinson's disease, seizure reduction rates for epilepsy, and specific tremor grading scales with clinical validation.
Continuous tracking of device longevity, battery depletion rates, lead migration or fracture, and surgical revision rates over a ten-year horizon to satisfy the strict post-market requirements for active implants.
Seamless Real-World Evidence (RWE) collection linked to national neuromodulation registries. We help manufacturers extract and contextualise big data to support indication expansion and legacy device certification.
Managing long-term neurostimulation follow-up requires a robust data infrastructure. Eclevar Medtech utilises MILO EDC, its proprietary Electronic Data Capture platform fully compliant with FDA 21 CFR Part 11 and GDPR. MILO integrates eCRF and automated ePRO surveys ‒ which are crucial for pain diaries ‒ into a single, audit-ready ecosystem designed to maximise patient retention over several years.
Eclevar Medtech manages the entire AIMD evidence continuum. This includes early pre-clinical strategy and feasibility studies, as well as rigorous Clinical Evaluation Reports and post-market surveillance programs.
Our team provides specialised medical expertise in active implantable medical device evaluation, regulatory strategy mapping, and PMCF program design tailored exclusively for neuromodulation and neurovascular technologies.
Because our clinical and data management architectures are designed by former Notified Body reviewers, your submission is built to withstand the strictest regulatory audits under Annex IX and X from day one.
Connect with our neuromodulation specialists to map out your pathway to EU MDR clinical compliance for your active implants.
