A short read on using the NJR and EPRD to build post-market clinical evidence under EU MDR: what the registries can and cannot prove, and how to turn that into a defensible PMCF strategy.
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
Orthopaedic and spine sponsors rely on Eclevar to turn registry data into Notified Body-ready PMCF. Read all client success stories.
Dr Nikhil Khadabadi, CMO for Orthopaedics and Spine and a former TÜV SÜD reviewer, designs registry strategy into the clinical evaluation from the start. The scale of the NJR and EPRD is only useful if your exact implant family, version history and regulatory claims are translated into a retrievable cohort and a defensible analysis plan.
National arthroplasty registries hold more longitudinal implant data than any prospective study could generate. Used well, that is post-market evidence at a scale reviewers respect.
Survivorship, revision patterns and comparative performance, versus the endpoints registries simply do not capture.
Start from the claim, get device identification exact, and be honest about confounding, bias and endpoint definitions.
Map claims to data, identify the residual gaps, and design only the lean complementary study that fills them.
| Registry | Country | Scale & scope |
|---|---|---|
| NJR National Joint Registry | United Kingdom | 4.6M+ procedure records across hip, knee, ankle, elbow and shoulder. |
| EPRD German Arthroplasty Registry | Germany | 2.63M+ hip and knee procedures since 2012, with around 76% national coverage in 2022 (voluntary registry). |
The hard part is translating your exact implant family, version history and regulatory claims into a retrievable registry cohort and a defensible analysis plan. That is what the full guide walks through.
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, the standard your registry evidence has to meet.
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, combining Eclevar's ISO 14155 clinical expertise with the Milo Studio platform.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »Antoine Turzi, CEO, RegenLab
Sometimes. Registries such as the NJR and EPRD prove survivorship, revision patterns and comparative performance, but they do not capture every endpoint. The method is to map your claims to registry data, identify the residual gaps, and design only the lean complementary study that fills them.
Primarily the NJR (National Joint Registry, UK) with over 4.6 million procedure records across hip, knee, ankle, elbow and shoulder, and the EPRD (German Arthroplasty Registry) with over 2.63 million hip and knee procedures since 2012 and around 76% national coverage in 2022.
Start from the claim, get device identification exact, and be honest about confounding, bias and endpoint definitions. The registry cohort must be a retrievable, defensible subset that maps to your specific implant family and version history.
Treating registry evidence as something to bolt on after the CER has already been written. Registry strategy should be designed into the clinical evaluation and PMCF plan from the start, not added at the end.
How to write an NJR or EPRD data-access application that returns the exact subset you need, when registry data genuinely replaces a prospective study and when it does not, designing the lean complementary study that fills only the real gaps, handling confounding, learning curves and device iteration, and structuring a single PMCF evaluation report a reviewer can follow end to end.
We will send you the 8-page registry PMCF guide and, when you are ready, map your exact implant family and claims to a defensible NJR or EPRD strategy on a 30-minute call.
