Joint replacements and spinal implants live in the body for a decade or more, so their PMCF cannot rest on a short pre-market study. Eclevar builds registry-based, survivorship-driven PMCF for orthopedic and spinal devices under EU MDR, with in-house biostatisticians and former Notified Body reviewers designing every plan. Get our free strategy cheat sheet to see the full playbook.
Registry-based PMCF · 7 countries
One accountable team builds your survivorship model, PROMs schedule and registry integration, on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders across orthopedics, spine, cardiovascular, wound care and more choose Eclevar. Read all client success stories.
PMCF for orthopedic and spinal devices is the proactive, continuous collection of clinical data on an implant already on the market, to prove its long-term safety and performance across the whole device lifetime.
Under EU MDR 2017/745 and MDCG 2020-7, post-market clinical follow-up is not optional for high-risk implantable devices. Hip and knee replacements, spinal cages, plates and screws are expected to function for ten to twenty years, and their true failure modes, aseptic loosening, polyethylene wear, periprosthetic fracture and revision, emerge long after a pre-market study closes. A short trial simply cannot demonstrate that the benefit-risk balance holds over that horizon.
That is why orthopedic PMCF leans on three pillars: registry-based real world evidence from national arthroplasty and spine registries, implant survivorship analysis with revision as the endpoint, and validated patient-reported outcome measures (PROMs) collected at defined follow-up points. Together they give a Notified Body the longitudinal evidence that a bespoke study rarely delivers alone.
Eclevar delivers this as one connected service, from post-market clinical follow-up and registry-based real world evidence through to the clinical evaluation report that keeps your CE certificate valid.
Eclevar's model brings the regulatory perspective inside the CRO, closing the gap between what orthopedic manufacturers submit and what assessors expect to read. Dr Mark Da Costa, COO and former TÜV SÜD reviewer, leads alongside Dr Nikhil Khadabadi, CMO for orthopedics and spine and also a former TÜV SÜD senior reviewer, so PMCF plans for implantable devices are designed the way a Notified Body wants to assess them, from the first version of the plan.
For a long-lived implant, how you design PMCF decides whether the evidence holds up ten years out. The gap between a copy-paste survey plan and a survivorship-led orthopedic strategy is structural.
Every step of a lifetime PMCF program for hip, knee and spine, designed to MDCG 2020-7 and captured with full traceability for Notified Body review.
A lifetime PMCF plan to MDCG 2020-7 that maps residual risks and open clinical questions for your implant, aligned from the outset to the clinical evaluation report.
Linkage to national arthroplasty and spine registries (NJR, EPRD, LROI and others) for population-scale real world evidence and revision tracking.
Kaplan-Meier time-to-revision modeling by our biostatisticians, benchmarked against registry and literature thresholds to demonstrate long-term performance.
Validated patient-reported outcome measures, Oxford Hip and Knee Scores, WOMAC, EQ-5D and the Oswestry Disability Index, captured on MILO Studio at defined follow-up points.
Structured post-market clinical follow-up surveys and, where needed, a focused PMCF study under ISO 14155 with in-house monitoring.
Survivorship, registry and PROMs data written up into the CER and Periodic Safety Update Report, backed by our ISO 13485 quality system.
One accountable team covers every stage of the implant evidence lifecycle, so nothing is lost between a PMCF plan, a registry dataset and a Notified Body submission.
Post-market investigations under ISO 14155, from feasibility and site selection through multi-country ethics submissions and on-site and remote monitoring.
The clinical evaluation report under MDCG 2020-6, PMCF Plans and SSCP, written by clinicians and reviewed by former Notified Body assessors.
100% in-house clinical data management and EDC: eCRF design, DMP and DVP, powered by MILO Studio, natively built for EU MDR.
Structured post-market clinical follow-up meeting MDCG 2020-7 Level 4 criteria, with validated questionnaires and MILO Studio capture.
National registry integration (NJR, EPRD, EUDAMED) for long-term real world evidence and survivorship follow-up of implantable devices.
Regulatory affairs and clinical strategy for CE mark pathways and equivalence, backed by a quality management system certified to ISO 13485.
An orthopedic manufacturer of a hip replacement system faced a Notified Body finding that its PMCF plan could not demonstrate long-term performance beyond the short pre-market cohort. Eclevar rebuilt the strategy around the orthopedic playbook: revision was set as the primary survivorship endpoint, national joint registry data was linked for population-scale follow-up, and validated PROMs (Oxford Hip Score and EQ-5D) were collected on MILO Studio at defined intervals.
Kaplan-Meier survivorship was benchmarked against registry and literature thresholds for the state of the art, and every dataset fed a clean, traceable file. When the Notified Body re-reviewed, the long-term evidence was complete and defensible, and it directly supported the clinical evaluation report and ongoing PMCF.
Outcome: a lifetime PMCF plan the reviewer accepted, survivorship evidence against the state of the art and a valid CE certificate, instead of a repeat nonconformity.
Former Notified Body reviewers from TÜV SÜD, including an orthopedics and spine lead. We know what fails inspection and design PMCF to avoid it.
Clinical ops, biostatistics, writing and data management. One point of accountability, no handoff fragmentation.
Proprietary EDC built natively for EU MDR, with Annex XIV mapping and AI eCRF generation for PROMs capture.
Paris, London, Tokyo and Pune. In-house CRAs in seven countries, not a network of subcontractors.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified. Every program structured for file completeness and Notified Body inspection readiness.
A network of employed CRAs and project leads, not subcontractors, gives sponsors consistent quality and one accountable team across the EU, the UK and Japan corridors.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any high risk implantable device program.
Eclevar manages RegenLab's PMCF program 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. »
Post-market clinical follow-up (PMCF) for orthopedic and spinal devices is the continuous, proactive collection of clinical data on an implant already on the market, to confirm long-term safety and performance under EU MDR 2017/745 and MDCG 2020-7. Because joint replacements and spinal implants are expected to function for ten to twenty years, orthopedic PMCF leans heavily on national registries, implant survivorship analysis and patient-reported outcome measures rather than short pre-market trials alone.
Orthopedic implants are long-lived, load-bearing and operator-dependent, so their real failure modes, aseptic loosening, wear, periprosthetic fracture and revision, often appear years after implantation. A short pre-market study cannot capture this, which is why EU MDR expects a lifetime PMCF plan built on registry data, survivorship curves and validated PROMs to show the benefit-risk profile holds over the device lifetime.
National arthroplasty and spine registries such as the NJR (England and Wales), EPRD (Germany), LROI (Netherlands) and the Swedish registries capture implant, procedure and revision data at population scale. Linked to a PMCF plan they provide long-term survivorship, benchmarking against the state of the art and early signals of underperformance, giving a Notified Body robust real world evidence that a bespoke study rarely matches on its own.
Survivorship analysis uses time-to-event (Kaplan-Meier) methods to estimate the probability that an implant remains in place without revision at, for example, five, ten or fifteen years, with revision as the primary endpoint. For orthopedic PMCF, survivorship benchmarked against registry and literature thresholds is the clearest evidence that a device's long-term performance meets or exceeds the state of the art.
Common validated patient-reported outcome measures include the Oxford Hip Score and Oxford Knee Score, the Harris Hip Score, WOMAC, EQ-5D for general health, and the Oswestry Disability Index and Neck Disability Index for spine. Structured PROMs collected at defined follow-up points turn subjective recovery into quantifiable clinical benefit that supports the clinical evaluation report and Level 4 PMCF surveys.
Eclevar designs a lifetime orthopedic PMCF plan to MDCG 2020-7, combining registry integration for survivorship, validated PROMs and, where needed, a focused PMCF study under ISO 14155. Data is captured on MILO Studio with full traceability, analyzed by our biostatisticians and written up by clinicians and former Notified Body reviewers so the evidence feeds the CER and PSUR without gaps.
The cheat sheet is a field-tested one-page map of the orthopedic PMCF playbook: which registries to use for hip, knee and spine, how to set survivorship endpoints and revision benchmarks, which PROMs to collect and when, and how to align the PMCF plan with the CER and Notified Body expectations so it passes first-round scrutiny. Request it and a specialist medical device CRO team sends it directly.
A field-tested playbook for hip, knee and spine: registries, survivorship endpoints and PROMs, mapped to your CER and Notified Body expectations. Talk to our specialists about your implant.
Get the free cheat sheetRegistry-based PMCF · Survivorship · Validated PROMs
