Medical device biometrics, under MDR and IVDR
Clinical investigations, IVDR performance studies, PMCF, and CER authoring — 70+ device studies delivered under the current EU regulatory framework. Diagnostic accuracy, clinical performance, comparative effectiveness, and the lifelong clinical-evaluation cycle MDR requires.
Medical-device biometrics is its own discipline.
The post-MDR regulatory landscape made medical-device clinical evidence as demanding as pharmaceutical clinical evidence — but the documentation chain, the statistical-methodology emphasis, and the operational expectations are different. Sponsors who treat device biometrics as "drug biometrics, but easier" find themselves with a CER the Notified Body queries and a PMCF plan that doesn\'t close the post-market loop.
Metronomia has supported 70+ medical-device studies — clinical investigations, PMCF studies, registries, surveys, and investigator-initiated trials. Our biostatistics bench brings the methodology depth in diagnostic accuracy, clinical performance, and comparative effectiveness that device sponsors actually need; our medical writers know the MDR / IVDR documentation chain end-to-end.
We work to ISO 14155 and ISO 20916, follow the MDR 2017/745 and IVDR 2017/746 frameworks, and integrate with EUDAMED submission requirements. For US-bound devices, we work alongside sponsors\' US regulatory partners on the statistical and clinical-evaluation sections of 510(k), De Novo, and PMA submissions.
The medical-device biometrics portfolio
Eight capability areas spanning pre-market clinical investigations through PMCF and CER lifecycle.
Clinical investigations (MDR)
Investigation-plan authoring and statistical leadership for pre-market clinical investigations under EU MDR (Regulation 2017/745).
IVDR studies
Performance and clinical-evidence studies under IVDR (Regulation 2017/746) — including diagnostic-accuracy and clinical-performance designs.
PMCF studies
Post-market clinical follow-up studies — registries, observational, single-arm long-term safety, comparative effectiveness.
Clinical Evaluation Reports (CER)
MDR-compliant CER authoring — literature review, equivalence assessment, post-market surveillance integration, benefit-risk discussion.
Survey & registry design
Patient registries, investigator-initiated trials, and structured surveys for real-world device performance.
Diagnostic-accuracy methods
Sensitivity, specificity, AUC, kappa agreement, ROC analysis; sample-size calculations for diagnostic studies.
Comparative effectiveness
Device-vs-device, device-vs-standard-of-care designs — randomised and observational, with appropriate causal-inference framing.
Submission documentation
CIP, CER, clinical-evaluation summary, PMCF plan and report — written by writers who understand the MDR / IVDR documentation chain.
Plan → conduct → analyse → report
A four-phase engagement aligned to MDR / IVDR documentation and the lifelong clinical-evaluation cycle.
- 01
Plan
Investigation Plan (CIP) or PMCF plan authored to MDR / IVDR template, with the statistical methodology grounded in the device class and clinical claim.
- 02
Conduct
EDC build, eCRF design, statistical execution. We support studies through Notified Body review and CTIS / IRIS submission where required.
- 03
Analyse
Pre-specified analyses plus post-market surveillance integration. Sensitivity analyses for the specific endpoint type (diagnostic accuracy, clinical performance, comparative effectiveness).
- 04
Report
CER and PMCF report authoring — feeding into the lifelong clinical-evaluation cycle MDR requires.
Device studies across the MDR / IVDR regulatory framework.
“Devices need the same biometric rigour as drugs — and a documentation chain MDR has made just as demanding. PMCF is where most sponsors realise their CER strategy needed to be designed before the first patient enrolled.”
Rebecca Farrar Head of Medical Writing