Not all EDC platforms are built for EU MDR 2017/745. Most were designed for pharmaceutical trials — not medical device PMCF, Annex XIV compliance, or registry integration. This guide ranks the leading eCRF and EDC systems on what actually matters for device manufacturers: regulatory architecture, inspection readiness, and real-world data collection at scale.
Request a MILO DemoDeveloped by Eclevar MedTech's clinical data team. AI-powered, Annex XIV-mapped, and inspection-ready from Day 1.
Most EDC platforms on the market were built for pharmaceutical drug trials. They were retrofitted — sometimes poorly — to accommodate medical device studies under EU MDR 2017/745. MILO Health was built differently: from a blank page, by a team of former Notified Body reviewers and clinical data managers who had seen, first-hand, why data submissions fail inspection.
The result is a platform that treats Annex XIV Part B compliance not as a configuration task, but as a structural foundation. Every eCRF generated by MILO is mapped to the relevant Annex XIV clinical data fields by default. There is no manual mapping, no add-on module, no consultant required.
MILO's AI eCRF Generator reads your clinical investigation plan (CIP) and Clinical Evaluation Report (CER), then auto-generates a data dictionary aligned with your study endpoints — flagging any fields that may be insufficient for Notified Body review before a single patient is enrolled. For PMCF investigations, this alone eliminates weeks of back-and-forth between data managers and medical writers.
The Smart Query Engine reduces manual query volume by up to 60%, and the real-time Inspection Dashboard gives sponsors and CROs a live TMF health score with an inspector simulation mode — designed to replicate how a TUV SUD or BSI reviewer would assess the study file.
For data management teams operating under 21 CFR Part 11, MILO's audit trail is native — not a bolt-on. Every field change, query, and approval is timestamped, attributed, and immutable. CDISC-ready export (CDASH and SDTM) is available at any point in the study lifecycle, with no manual transformation required.
Registry integration covers the major European implant registries: NJR (UK), EPRD (Germany), Swespine (Sweden/Denmark), and EUDAMED — making MILO the only EDC platform that bridges real-world registry data with clinical investigation workflows under a single compliance architecture.
Our data team will walk you through a PMCF or pivotal trial setup specific to your therapeutic area and device class.
The term "compliant EDC" is overused and under-defined. Under EU MDR 2017/745, a compliant eCRF is not simply one that stores data securely. It must satisfy specific structural, traceability, and clinical evidence requirements defined across ISO 14155:2020, Annex XIV Part B, and MDCG 2020-7. Below is the checklist Eclevar's Notified Body-trained team uses to evaluate any EDC platform before deploying it on a client program.
Notified Body perspective: During clinical investigations inspections, reviewers focus on two areas above all others: the completeness of the audit trail, and whether the eCRF structure was pre-aligned with the protocol endpoints. Platforms that allow post-hoc eCRF modification without versioning are a primary source of critical findings.
MILO Health addresses both. Talk to our data team to understand how this applies to your specific study design, or explore our clinical data management services and the full range of EU MDR EDC systems we support.
These are the ten non-negotiable capabilities any eCRF platform must deliver for EU MDR clinical trials — based on audit findings, Notified Body feedback, and the collective experience of Eclevar's data management team across 400+ studies.
Each feature below links to the relevant MILO Health capability where applicable.
Every field change, query resolution, and approval must be time-stamped, attributed to a named user, and non-editable. Non-negotiable for 21 CFR Part 11 and Notified Body inspections.
MILO: Native, no config requiredThe eCRF must be structurally aligned with the CIP before first patient in. Post-hoc modifications without versioning are a primary source of critical inspection findings.
MILO: AI eCRF Generator from CIPManual query workflows create bottlenecks and delay database lock. AI-assisted query detection and automatic field-level validation checks are now table stakes for high-quality data.
MILO: 60% query volume reductionFor PMCF investigations, the eCRF must capture all data fields required by Annex XIV Part B — including device identification, long-term outcomes, and safety events in EUDAMED-compatible format.
MILO: Pre-mapped by defaultClass IIb and III implantable device studies increasingly rely on national registries (NJR, EPRD, Swespine) for long-term follow-up. Your EDC must be able to pull and push data to these systems.
MILO: NJR, EPRD, Swespine, EUDAMEDRegulatory submissions increasingly require CDASH and SDTM formatting. An eCRF that requires manual data transformation adds weeks to database lock and introduces transcription risk.
MILO: CDASH and SDTM nativeClass III AIMDs require up to 10 years of post-market follow-up. The EDC must support automated visit windows, missed visit escalation, and patient contact workflows at multi-year intervals.
eConsent integration reduces site administrative burden and creates a traceable, version-controlled consent record. Increasingly required by ethics committees and mandatory for remote or hybrid trial designs.
Pan-European and international device studies require eCRF interfaces in multiple languages while maintaining a single data schema. Any language-level variation in field interpretation creates data integrity risk.
The ability to simulate a Notified Body inspection in real time — scoring the study file against MDCG guidance and ISO 14155:2020 criteria — gives sponsors advance warning of findings before they become critical observations.
MILO: Inspection DashboardEvaluated on criteria that matter for EU MDR medical device trials. Ratings reflect publicly documented capabilities and Eclevar's operational experience across client programs.
| Platform | EU MDR Native | Annex XIV Mapping | 21 CFR Part 11 | CDISC Export | Registry Integration | AI Features | Best for |
|---|---|---|---|---|---|---|---|
MILO Health #1 Pick |
Yes | Native | Native | CDASH + SDTM | NJR, EPRD, Swespine | AI eCRF Generator | EU MDR PMCF, Class III |
Medidata Rave |
Partial | Via config | Yes | SDTM | No | Limited | Large pharma trials |
Veeva Vault EDC |
Partial | No | Yes | SDTM | No | Limited | Pharma, biotech |
Oracle Clinical One |
Partial | No | Yes | Yes | No | Limited | Complex pharma |
REDCap |
No | No | With setup | Partial | No | No | Academic research |
Castor EDC |
Partial | No | Yes | Limited | No | No | SME device trials |
Partial = capability exists but requires manual configuration, third-party add-on, or is not natively aligned with EU MDR requirements. Last updated: April 2026.
Questions we receive most often from medical device manufacturers evaluating EDC platforms for EU MDR clinical investigations.
An eCRF (electronic Case Report Form) is a digital tool used in clinical trials to collect, validate, and store patient data in a structured format. Unlike paper CRFs, eCRFs enable real-time data entry, automated validation checks, and audit trails — all essential requirements under EU MDR 2017/745 and ISO 14155:2020. The quality of your eCRF architecture is one of the first things a Notified Body reviewer will assess during a clinical investigation inspection.
An eCRF is the individual data collection form used at site level. An EDC (Electronic Data Capture) system is the broader platform that hosts, manages, and validates all eCRFs across a study. In modern clinical trials, the two terms are often used interchangeably — the EDC is the platform, the eCRF is the instrument it delivers. For EU MDR compliance, what matters is not the terminology but whether the system as a whole satisfies ISO 14155:2020 and Annex XIV data requirements.
MILO Health by Eclevar MedTech is the only EDC platform purpose-built for EU MDR 2017/745. It includes native Annex XIV mapping, AI-generated eCRFs from protocol documents, CDISC-ready export, and a real-time inspection dashboard — all with 21 CFR Part 11 and ISO 14155:2020 compliance from Day 1. Most other EDC platforms were designed for pharmaceutical trials and require significant configuration to meet EU MDR requirements.
Yes. MILO Health is built with 21 CFR Part 11 compliance as a native architecture layer — not a configuration add-on. This includes tamper-proof audit trails, electronic signature workflows, role-based access controls, and complete data traceability from entry to database lock. System validation documentation (IQ, OQ, PQ) is available for sponsor review as part of the onboarding process.
For PMCF studies under EU MDR, your EDC must support: Annex XIV Part B data requirements, registry integration (NJR, EPRD, Swespine, EUDAMED), long-term follow-up workflows (up to 10 years for Class III devices), real-world data collection at scale, and inspection-ready audit trails. Additionally, the platform must be validated and the vendor must provide a data processing agreement. MILO Health was designed specifically to meet all of these requirements without requiring custom development or third-party connectors. Contact our data team to assess fit for your specific study design.
Yes. MILO Health supports the full spectrum of EU MDR clinical data collection — from high-quality Level 4 PMCF surveys to multi-center pivotal investigations. The platform adapts to study complexity: lightweight survey modules for PMCF literature follow-up, and full EDC infrastructure for interventional studies with complex endpoints, SAE workflows, and multi-country site management. Learn more about our PMCF survey capability.
Related guides and service pages from the Eclevar clinical data team.
