Clinical data management software built for pharmaceutical trials does not satisfy EU MDR 2017/745. This guide covers what ISO 14155:2020-compliant data management actually requires — and how MILO Health, Eclevar's proprietary EDC, delivers it without configuration risk.
Clinical data management (CDM) covers the full lifecycle of clinical data — from eCRF design through database lock. Under EU MDR and ISO 14155:2020, every stage must be pre-specified, version-controlled, and traceable.
Clinical data management for medical devices under EU MDR 2017/745 is significantly more complex than the term suggests. It is not simply data entry and storage. It is a regulated, multi-stage process that must be governed by a pre-specified Data Management Plan (DMP) and Data Validation Plan (DVP) — both of which must be approved before any eCRF configuration begins.
Under ISO 14155:2020 (the governing standard for clinical investigations of medical devices in human subjects), data management must satisfy requirements across data validation, query management, medical coding, audit trail integrity, and database lock procedures. Each of these stages has specific documentation requirements that a Notified Body assessor will review during technical file audit and surveillance visits.
The critical difference between CDM for pharmaceutical trials and CDM for EU MDR medical device trials lies in the Annex XIV Part B data requirements. Device-specific fields — UDI-DI and UDI-PI capture, device identification at explant, adverse event coding aligned with EUDAMED, and long-term follow-up scheduling for Class III AIMDs — are not present in standard pharmaceutical EDC configurations. They must be built in from the beginning.
Eclevar's clinical data management is 100% in-house. No subcontractors, no outsourced pipelines, no handoff risk. Our data managers sit alongside project managers, CRAs, and medical writers — in the same team, under the same accountability structure, from Day 1 to database lock.
Governing document for all CDM activities. Must be approved before eCRF build begins. Defines roles, responsibilities, data flows, and validation approach.
Pre-specified edit checks, field-level validation rules, and eCRF architecture. All modifications after build must be version-controlled with documented justification.
Automated and manual query generation, site response tracking, and resolution documentation. Full query audit trail mandatory under 21 CFR Part 11.
MedDRA coding for adverse events, EUDAMED-compatible serious adverse event reporting. Version-controlled against study-specific coding convention document.
Formal data review, discrepancy resolution, biostatistician sign-off, database lock declaration. CDISC CDASH/SDTM export for submission-ready datasets.
Most CROs outsource clinical data management. The pipeline typically runs: sponsor to CRO project manager, to external data manager, to external EDC vendor, to external biostatistician. Every handoff is a version control risk. Every external vendor is a TMF audit finding waiting to happen.
Eclevar's data management is entirely in-house. Our data managers, biostatisticians, and EDC specialists are Eclevar employees — not subcontractors. They sit in the same team as the clinical project manager and the medical writer. When a query needs resolving, there is no email chain — there is a conversation.
The practical result: query volumes are lower, database lock timelines are shorter, and the audit trail is cleaner. Under ISO 14155:2020, a single accountability chain from DMP to database lock is not just operationally efficient — it is a compliance architecture choice.
Most EDC platforms were designed for pharmaceutical trials. They were adapted — sometimes poorly — for medical device use. MILO Health was built from a blank page, by a team that had seen first-hand what data failures look like from a Notified Body's perspective.
| Capability | Paper / Excel | Standard EDC (Pharma-adapted) |
MILO Health
EU MDR Native
|
|---|---|---|---|
| Setup time | Immediate — no setup | 8–16 weeks configuration + validation | 2–4 weeks — AI eCRF from CIP document |
| Annex XIV Part B mapping | Manual — no structure | Not available natively — custom build required | Pre-configured in all eCRF templates |
| 21 CFR Part 11 audit trail | Not possible | Available — requires configuration and validation | Native architecture — no configuration required |
| eCRF generation | Manual spreadsheet | Manual eCRF build — weeks per study | AI generator reads CIP + CER, auto-builds eCRF |
| Query management | Email / spreadsheet tracking | Automated — standard pharma workflow | Smart Query Engine — 60% volume reduction vs standard EDC |
| CDISC export (CDASH/SDTM) | Manual transformation — weeks | Available — requires mapping and validation | Native export at any study stage — no transformation |
| Registry integration (NJR, EPRD, Swespine) | Not possible | Not available — custom development required | Native connectors — data reconciliation in-platform |
| Inspection dashboard (TMF score) | Not possible | Not available | Real-time TMF health score with inspector simulation |
| Long-term follow-up (10yr AIMDs) | Manual scheduling | Available — requires configuration | Native scheduling module — automated visit windows and escalation |
| EUDAMED-compatible SAE coding | Manual — no coding structure | Requires custom build | Built-in MedDRA coding with EUDAMED export |
MILO Health is available as a standalone platform or as part of Eclevar's full clinical data management service. Request a live demonstration tailored to your device class and indication.
Request a MILO demoComparison based on publicly documented capabilities of standard EDC platforms and Eclevar's operational experience across 400+ medical device studies. Last reviewed April 2026.
Every service below is delivered by Eclevar's internal team. No outsourcing, no subcontractors. One accountability chain from DMP to database lock.
ISO 14155:2020-compliant DMP covering roles, responsibilities, data flows, validation approach, and edit check specifications. Approved before any eCRF configuration.
Annex XIV-mapped eCRF templates, field-level validation rules, and EDC build using MILO Health. AI eCRF Generator reads your CIP and CER — reducing setup time by up to 70%.
MILO's Smart Query Engine reduces manual query volume by up to 60%. All queries tracked, resolved, and documented in the 21 CFR Part 11-compliant audit trail.
Adverse event and concomitant medication coding using MedDRA. EUDAMED-compatible SAE coding and reporting workflows. Version-controlled against study coding convention document.
Statistical Analysis Plan (SAP) production, interim and final analyses, database lock declaration. CDISC CDASH and SDTM export ready for regulatory submission without manual transformation.
MILO Health's registry integration layer connects to NJR, EPRD, Swespine, and EUDAMED. Real-world registry data reconciled with eCRF data in a single platform environment.
Clinical data management (CDM) in medical device trials covers the full data lifecycle — from eCRF design and DMP production through data entry, query management, medical coding, and database lock. Under EU MDR and ISO 14155:2020, CDM must be governed by a pre-specified DMP and DVP, with a 21 CFR Part 11-compliant audit trail from first patient in to database lock. It is a regulated deliverable, not a back-office function.
MILO Health by Eclevar MedTech is the only EDC platform built natively for EU MDR 2017/745. Unlike pharma-adapted systems, MILO includes Annex XIV Part B field mapping, AI-generated eCRFs from the CIP, 21 CFR Part 11-compliant audit trails as native architecture, CDISC CDASH/SDTM export, and registry integration — without requiring custom configuration or third-party modules. See the comparison table above for a full breakdown.
100% in-house CDM eliminates handoff risk at every stage. When data managers sit alongside project managers and medical writers, query resolution is faster, version control is simpler, and the audit trail is cleaner. Outsourced pipelines introduce communication delays, version control complexity, and accountability fragmentation — all of which are primary inspection findings under EU MDR and ISO 14155:2020.
A Data Management Plan is a study-level governance document that defines all CDM activities, roles, responsibilities, data flows, validation approach, and edit check specifications. Under ISO 14155:2020, the DMP must be approved before any eCRF configuration begins. A DMP produced after the eCRF build — or one that mirrors the eCRF structure rather than pre-specifying it — is a primary audit finding. Eclevar produces the DMP as the first CDM deliverable on every program.
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30 years of clinical data management experience, 400+ medical device studies, and the only EDC platform built natively for EU MDR. Eclevar's data team handles everything in-house — from DMP to database lock.
