EU MDR · Ortho · PMCF
PMCF for orthopedic devices, built on the registries.
Orthopedics has something most specialties lack: mature national implant registries. Used well, they make PMCF efficient. Here is how to build long-term ortho evidence.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Ortho PMCF, led by an ortho reviewer.
Orthopedic PMCF is a specialty in itself. Ours is led by a former Notified Body reviewer for Class III implants.
Dr Nikhil Khadabadi
Former Notified Body assessor for Class III implants; PMCF and CER methodology, ortho and high-risk devices.
in LinkedIn
Sébastien Meier
Endpoints, statistics and RWE; architect of the MILO EDC, 21 CFR Part 11 and real-time dashboards.
Awards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The strategy
Why run a trial when the registry already has the data?
National implant registries capture revision and survivorship data at a scale no single study can match. The art of ortho PMCF is using them well, and knowing when they are not enough.
01
The registry advantage
Registries like the NJR (UK), EPRD (Germany) and Swespine capture large-scale, long-term outcome data, above all implant survivorship and revision rates. For many hip, knee and spine devices, registry data is the most efficient route to the real-world evidence PMCF requires.
02
Where registries fall short
Registries are powerful but not complete.
When registry data is not enough
- Novel devices with too little registry exposure yet
- Endpoints registries do not capture (function, PROs, imaging)
- Specific claims needing controlled comparison
- Early signals needing prospective confirmation
03
The hybrid PMCF design
The strongest ortho PMCF blends both: registry data for survivorship and revision at scale, and a lean prospective observational study or PRO survey for function and patient-reported outcomes the registry misses. Each covers the other’s blind spot.
04
Making it Notified-Body-ready
Whatever the mix, the PMCF plan must tie each data source to a specific evidence gap in the CER, so a reviewer can see why registry data answers one question and a study answers another. We design the plan so it survives the technical file audit.
Ortho PMCF
Registry plus study.
Talk to a specialist
What is the leanest PMCF for your orthopedic device?
Book a free scoping call with a former Notified Body ortho reviewer. We design a registry-plus-study PMCF matched to your claims.
Book a free scoping callFor orthopedics, the registry is your PMCF head start.
An expert read designs a registry-plus-study PMCF matched to your device and claims, so you get robust evidence without over-building the study.
Book a free scoping callQuestions we hear first