Eclevar MedTech is a specialist orthopaedics and spine CRO in Europe, supporting manufacturers of joint, spinal and trauma implants across the entire clinical lifecycle: from initial feasibility to registry-linked PMCF and long-term surveillance under Annex XIV of the EU MDR.
Total hip and knee replacement systems, primary and revision implants.
Interbody cages, rods, pedicle screws and complex fusion devices.
Plates, screws, nails and external fixation systems for fracture management.
Bone graft substitutes, osteoinductive materials and synthetic scaffolds.
Manufacturers choose Eclevar as their specialist orthopaedics and spine CRO. See client testimonials.
A former assessor at TÜV SÜD, one of Europe's most rigorous Notified Bodies, Dr Khadabadi has reviewed clinical evidence dossiers for hundreds of orthopaedic and spinal implants. He now leads Eclevar MedTech's orthopaedics and spine practice, building PMCF programmes, registries and clinical evaluation reports (CER) designed to pass stringent regulatory audits at first submission.
Under the EU Medical Device Regulation (EU MDR), orthopaedic and spinal implants face unprecedented clinical scrutiny. Legacy equivalence claims are no longer sufficient: Notified Bodies require long-term clinical and safety data, the integration of radiographic endpoints and continuous PMCF for Class IIb and Class III devices.
Demonstrating clinical safety requires more than patient questionnaires. Eclevar MedTech integrates standardised imaging protocols into your PMCF to track bone fusion, osseointegration and radiolucency precisely over time.
Orthopaedic and spinal implants must perform for decades. We design ten to fifteen year PMCF follow-up strategies that meet Notified Body survivorship expectations, without blowing your budget.
Many legacy devices lack the structured clinical data now required by Annex XIV. Eclevar MedTech remediates historical data and designs high-quality real-world evidence (RWE) registries to close these gaps quickly.
A structured delivery process that connects regulatory strategy, study operations and digital data capture into a single coordinated evidence journey.
Assessment of clinical data and literature against Annex XIV to identify device-specific risks.
Design of clinical investigations, surveys or registry-based PMCF plans tailored to your implant.
Deployment of validated MILO EDC for secure multicentre data collection and radiographic imaging.
Activation of our specialist network of orthopaedic investigators and clinics across Europe.
Drafting of audit-ready CERs and PMCF evaluation reports for the Notified Body.
Implementation of validated patient-reported outcome measures (PROMs) specific to joint and spinal indications: Oxford Hip and Knee scores, Oswestry Disability Index (ODI) and Neck Disability Index (NDI).
Standardised assessment protocols: implant migration, subsidence, bone fusion rates and radiolucency, with independent core lab validation.
Collection of real-world evidence (RWE) linked to national and European joint registries (NJR, EPRD). Eclevar helps manufacturers extract and contextualise legacy device data.
Continuous monitoring of revision rates, implant survivorship by Kaplan-Meier analysis and adverse events over a ten to fifteen year horizon.
Managing long-term orthopaedic follow-up requires robust data infrastructure. Eclevar MedTech relies on MILO EDC, a proprietary platform fully compliant with 21 CFR Part 11 and GDPR, integrating eCRF, ePRO and secure radiographic image storage in a single, audit-ready environment.
Eclevar MedTech manages the entire evidence continuum, from pre-clinical strategy and feasibility studies through to rigorous CERs and post-market surveillance programmes.
Decades of expertise dedicated to orthopaedics and spine. The same specialist model drives our cardiovascular CRO practice.
Our clinical and data architectures are designed with the insight of former Notified Body assessors: your submission withstands the most stringent audits from day one.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with the Notified Body BSI: a practical reading of clinical evidence expectations under the EU MDR 2017/745, useful for any high-risk device programme, orthopaedic implants included.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
Where our consultants, including our former Notified Body expert, are speaking and what we are building.
The Eclevar team, including our former Notified Body expert, on what clinical trials need to satisfy Notified Body review.
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Dr Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on the EU MDR and the introduction of new devices.
View the session ↗Our award-winning platform reads a protocol and returns three costed scenarios (fast, base, conservative) along with a recruitment forecast.
Explore the platform ↗Look for orthopaedics-specific methodology (validated PROMs such as Oxford, ODI and NDI scores, radiographic endpoints with core lab validation, registry integration), Notified Body knowledge within the team, and a data platform built for long-term follow-up. Eclevar brings these pillars together, with its orthopaedics and spine practice led by a former TÜV SÜD assessor.
Legacy equivalence claims are no longer sufficient. Notified Bodies require long-term clinical and safety data, the integration of radiographic endpoints and continuous PMCF for Class IIb and Class III devices.
We integrate standardised imaging protocols into PMCF to track bone fusion, osseointegration, implant migration, subsidence and radiolucency, with independent core lab validation and secure DICOM storage within MILO EDC.
Yes. We design ten to fifteen year PMCF follow-up strategies that meet Notified Body expectations, combining clinical scores, registry-linked real-world data and Kaplan-Meier survivorship analysis in a proportionate design.
Many legacy devices lack the structured clinical data required by Annex XIV. We remediate historical data and design high-quality real-world data registries, linked to national and European joint registries.
Dr Nikhil Khadabadi, Chief Medical Officer for orthopaedics and spine. A former assessor at TÜV SÜD, he now builds PMCF programmes, registries and CERs designed to pass stringent audits at first submission.
Device-specific clinical evidence, not generic protocols, for implants, fixation systems and spinal devices under EU MDR 2017/745.
We design first-in-human studies around staged enrolment, independent safety monitoring (DSMB), imaging and biomechanical endpoints, and early PMCF planning, under ISO 14155:2026, with a former Notified Body reviewer reading the strategy from the assessor's side.
Spine clinical evaluation cannot rest on market history alone. We build device-centric CERs using validated PROMs (ODI, VAS, EQ-5D), registry data, structured equivalence analysis and a defensible trial-design rationale.
Why market history is not enoughRegistry follow-up is only one PMCF tool. For orthopaedic and spine devices we also run PMCF surveys, observational studies, real-world evidence collection and PROM-based follow-up, aligned with MDCG 2020-7.
Our PMCF activitiesA European spinal implant manufacturer needed post-market clinical evidence to keep its Class III fusion system compliant under EU MDR 2017/745, with data scattered across surgeon-held records. We designed a registry-based PMCF study aligned with MDCG 2020-7, standardised PROM collection (ODI, VAS, EQ-5D) across 12 EU investigator sites over a 24-month horizon, and integrated the data into a validated EDC (ISO 14155:2026, 21 CFR Part 11). Outcome: a single, inspection-ready clinical dataset that supported the device's CER update and its certification pathway.
Illustrative anonymised example based on typical orthopaedic and spine PMCF engagements.
Speak with our orthopaedics & spine specialists to map your path to EU MDR clinical compliance.
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