Orthopaedic and spine implants represent one of the most scientifically demanding areas in medical device development. These implants must function safely and effectively inside the body for years or even decades, often under significant biomechanical stress. Because of this, clinical evaluation and post-market follow-up are not one-time activities but continuous responsibilities throughout the life of the device.
Under the European Medical Device Regulation (MDR), manufacturers of orthopaedic and spine implants must demonstrate that their devices continue to perform as intended while maintaining an acceptable risk-benefit profile. Evidence must be robust, traceable, and linked to specific device identifiers such as UDI or implant stickers.
Total hip and knee replacements requiring long-term performance monitoring and osseointegration assessment.
Intervertebral cages, rods, and fusion devices demanding biomechanical stability evidence.
Osteosynthesis systems requiring evidence of mechanical reliability and healing outcomes.
Bone regenerative and joint preservation implants with unique clinical benefit claims.
Eclevar MedTech partners with manufacturers at every stage of the device lifecycle. Our teams support early clinical concept studies, pivotal trials, registry integration, and long-term performance monitoring. We help clients navigate evolving regulatory expectations while ensuring that clinical data collection is both scientifically sound and operationally efficient.
Get instant access to our comprehensive guide for orthopaedic devices under EU MDR.
Download NowThe MDR has transformed how orthopaedic evidence is evaluated. Notified Bodies now require manufacturers to go far beyond literature summaries or bench testing. Every claim made in the Clinical Evaluation Report must be supported by real-world or clinical data reflecting the actual device design and intended use.
Eclevar's regulatory and clinical experts include former Notified Body reviewers who have directly assessed orthopaedic submissions under MDR Annex XIV. We understand the nuances of reviewer expectations, from how to phrase performance objectives to how to demonstrate that follow-up design is proportionate to device risk.
Our goal is to help each client achieve a defensible, inspection-ready evidence package that withstands regulatory scrutiny.
Eclevar MedTech provides an integrated service pathway that connects regulatory strategy, study operations, and digital data collection into one coordinated process.
Our teams begin with a systematic review of existing clinical and real-world data to identify what evidence already supports the device and where uncertainties remain. This forms the foundation for a data-driven PMCF plan under Annex XIV.
Together with the sponsor, we select the most efficient design—whether registry-based, prospective cohort, or survey-based—to address the identified evidence gaps. Study design always reflects device risk, available data, and Notified Body feedback.
Using Milo Health EDC-enabled electronic data capture system, we integrate eSource, registry, and imaging data into one compliant environment. This reduces manual entry, enhances accuracy, and gives sponsors real-time visibility into follow-up progress.
We coordinate directly with investigators and surgical teams to ensure consistent data capture and follow-up adherence. Eclevar's dedicated CRO operations staff manage onboarding, monitoring, and ongoing support across multiple countries and languages.
Our biostatisticians and regulatory writers transform raw data into meaningful conclusions that support regulatory submissions. Outputs include PMCF Evaluation Reports, Clinical Evaluation updates, PSUR inputs, and registry performance summaries.
This structured workflow ensures that every orthopaedic study remains traceable, auditable, and ready for both regulatory and reimbursement evaluation.
Watch our expert panel discussion on how Real-World Evidence is transforming orthopaedic device development and regulatory compliance under EU MDR.
Watch Full ReplayModern orthopaedic evidence generation increasingly depends on real-world data. National and regional registries, hospital databases, and digital monitoring tools provide powerful opportunities to capture outcomes at scale. However, data quality and traceability must be proven before such information can be used in clinical evaluation.
Eclevar supports manufacturers in designing registry-linked PMCF programs that meet MDR standards for scientific validity. We define inclusion criteria, quality controls, and statistical analysis plans to ensure data integrity. Through our collaboration with the Milo Health platform, sponsors can merge registry data with eSource and imaging files to create unified datasets suitable for regulatory use.
Our experience covers a wide range of endpoints including:
We also advise on the incorporation of sensor or wearable data in early post-operative monitoring when clinically justified, enabling real-time performance assessment and early detection of potential complications.
Through our collaboration with the Milo Health platform, sponsors can merge registry data with eSource and imaging files to create unified datasets suitable for regulatory use, ensuring complete traceability from implant to outcome.
Eclevar MedTech's orthopaedic and spine practice combines surgical insight, regulatory depth, and data science.
Led by Dr Nikhil Khadabadi, Orthopaedic Surgeon and Chief Medical Officer (Orthopaedics and Spine), our team has supported manufacturers across Europe, Japan, and India in developing compliant PMCF and RWE strategies for joint, trauma, and spine implants.
Long-term performance monitoring and osseointegration studies
Biomechanical stability and fusion rate assessment
Mechanical reliability and healing outcome studies
Clinical benefit demonstration and long-term safety monitoring
Beyond regulatory support, Eclevar works with clinical investigators, academic networks, and hospital data teams to create continuous learning loops between design, use, and outcomes. We help manufacturers interpret field feedback and registry trends to drive both product improvement and clinical confidence.
Our collaborations with digital imaging partners and AI specialists allow advanced analysis of radiographs and CT scans to quantify implant performance in real time.
Patient-reported outcome measures are captured through integrated survey modules within Milo Health, ensuring long-term evidence of clinical benefit.
Eclevar MedTech is more than a contract research organisation. We are a global evidence partner that combines regulatory expertise, clinical insight, and digital technology to accelerate compliance and innovation.
We manage the complete evidence lifecycle from protocol to submission with one integrated team across regulatory, data, and clinical domains.
Our team has decades of experience in implant assessment, registry linkage, and surgeon-led PMCF program design.
The connection with Milo Health enables real-world data collection, automated edit checks, and traceability from implant sticker to report.
