Updated 2026 , EU MDR & ISO 14155:2026 Edition
Electronic informed consent under EU MDR 2017/745 is not simply a digital signature , it is a regulated, version-controlled process governed by ISO 14155:2026 and GDPR Article 9. This guide evaluates the top eConsent platforms on what actually matters for medical device clinical investigations across Europe.
Before selecting an eConsent platform, manufacturers and CROs must understand the specific regulatory requirements that govern electronic informed consent in EU MDR medical device clinical investigations. These requirements are more demanding than most pharmaceutical-oriented eConsent platforms are designed to meet.
ISO 14155:2026 (Section 7.4) governs informed consent in medical device clinical investigations. The standard requires that consent is prospective, voluntary, documented, and that participants have adequate time to consider participation. For eConsent, the platform must create a traceable, immutable consent record.
Under GDPR, health data in clinical trials qualifies as special category data under Article 9. eConsent platforms used in EU MDR investigations must comply with GDPR requirements for explicit, granular consent , distinguishing between consent for participation, data processing, and secondary research use.
Pan-European medical device trials add complexity to eConsent implementation. Ethics committee requirements vary by country , French CPP, German ethics committees, UK HRA, Italian CEI , and each may impose specific eConsent format or language requirements that must be managed at platform level.
Many eConsent implementations are deployed as standalone tools, disconnected from the eCRF environment. Under ISO 14155:2026, consent status must be traceable to study procedures at subject level. Without integration, this requires manual reconciliation , which is a version control and audit trail risk. Eclevar practic
Ranked by EU MDR and ISO 14155:2026 suitability, GDPR compliance architecture, multi-language capability, and EDC integration depth. Pharma-focused platforms without specific medical device compliance features are ranked lower regardless of market share.
The only eConsent solution built as an integrated module of an EU MDR-native EDC platform. MILO Health's eConsent is not a standalone tool , it is architecturally connected to the eCRF environment, meaning consent status, version control, and withdrawal tracking are unified with clinical data collection in a single, 21 CFR Part 11-compliant audit trail. Annex XIV mapping, multi-country consent form management, ISO 14155:2026 re-consent workflows, and GDPR Article 9 data segregation are native features. Available standalone or as part of Eclevar's full clinical data management service.
EU MDR native ISO 14155:2026 21 CFR Part 11 GDPR Art. 9 eCRF integrated Multi-language Re-consent workflow
Strong TMF integration and document management. eConsent module integrates well within the Veeva ecosystem for sponsors already using Vault. GDPR compliance architecture is solid. Limited out-of-box medical device-specific features , Annex XIV alignment and ISO 14155:2026-specific re-consent workflows require custom configuration. Strong for large enterprise sponsors; less suitable for SME device manufacturers or CRO-managed studies.
Market-leading eConsent within the Medidata ecosystem. Strong audit trail and 21 CFR Part 11 compliance. Designed for pharmaceutical trials , medical device-specific features (ISO 14155:2026 section mapping, Annex XIV data linkage) require custom build. Integration with Rave EDC is seamless within the Medidata environment but adds significant cost. Best suited to large-scale, multi-country studies where Medidata is already the EDC of choice.
Strong decentralised clinical trial (DCT) and remote eConsent capability. Multi-language support is a genuine differentiator for European multi-country studies. GDPR architecture is well-documented. Audit trail quality is high. Primary limitation for EU MDR use cases: no native integration with medical device-specific EDC environments, and device-specific consent elements require manual configuration.
Castor offers integrated eConsent within its EDC platform , an advantage for SME device manufacturers seeking a unified solution. ISO 14155:2026 alignment is reasonable out-of-the-box. GDPR compliance is documented. Primary limitation: Annex XIV-specific data linkage and Class III AIMD-specific consent elements are not natively supported. Better suited to Class IIa/IIb studies than Class III pivotal investigations.
Site-centric eConsent and eTMF platform with strong US market presence. EU regulatory alignment is improving but not yet at the level of purpose-built EU MDR solutions. GDPR compliance architecture requires sponsor-level validation. Good for US-EU parallel submission programs where a single eConsent platform is needed across FDA and EU MDR investigations.
Hospital and site-management-focused eConsent solutions with strong integration into hospital information systems (HIS). Relevant for EU MDR investigations conducted entirely within hospital settings with existing HIS infrastructure. Limited standalone EDC integration and limited EU-specific regulatory compliance documentation.
Academic and registry-focused eConsent capability. Not validated for regulated EU MDR clinical investigations out-of-the-box , validation requires institutional resources. GDPR compliance depends entirely on local institutional configuration. Not recommended for Class IIb or Class III pivotal investigations, where audit trail integrity requirements are strictest.
Electronic signature infrastructure adapted for clinical consent workflows. 21 CFR Part 11 e-signature compliance is robust. Limited clinical-trial-specific features , no native eCRF integration, no re-consent workflow management, no protocol version tracking. Better suited as a signature component within a broader eConsent workflow than as a standalone clinical eConsent solution.
e-signature 21 CFR Part 11 Limited CTM
Patient-experience-focused eConsent with strong multimedia consent capabilities. Engaging participant interface design. EU regulatory compliance documentation is limited compared to purpose-built clinical trial platforms. Suitable for studies where participant engagement and consent comprehension are the primary priorities, in combination with a separate EDC platform managing the regulatory compliance layer.
Evaluated on criteria specific to EU MDR 2017/745 medical device clinical investigations. Pharma-oriented features not listed , the focus is on device-specific compliance requirements.
Ratings based on publicly documented capabilities. Last reviewed April 2026. Always verify against current vendor documentation before platform selection.
| Criterion | MILO Health | Medidata Rave | Veeva Vault | Castor EDC | Signant |
|---|---|---|---|---|---|
| ISO 14155:2026 native alignment | Native | Via config | Via config | Partial | Partial |
| 21 CFR Part 11 audit trail | Native | Yes | Yes | Yes | Yes |
| GDPR Article 9 architecture | Native | Documented | Documented | Documented | Documented |
| Annex XIV data linkage | Native | Custom build | Custom build | Not available | Not available |
| eCRF integration (unified audit trail) | Native | Medidata only | Veeva only | Castor only | No |
| Re-consent workflow (protocol amendment) | Native | Yes | Yes | Partial | Yes |
| Multi-language (pan-European) | Yes | Yes | Yes | Limited | Yes |
| Remote / decentralised eConsent | Yes | Yes | Yes | Limited | Yes |
| System validation documentation | Available | Available | Available | Available | Available |
| Class III AIMD-specific features | Native | Not available | Not available | Not available | Not available |
eConsent is not explicitly mandated by EU MDR 2017/745, but ISO 14155:2026 requires that informed consent be documented in a traceable, version-controlled manner. eConsent platforms satisfy these requirements and are increasingly expected by ethics committees across France, Germany, and the UK. For multi-country investigations, eConsent significantly reduces administrative burden and ensures version-controlled consent records across all sites.
ISO 14155:2026 Section 7.4 requires: consent obtained before any study procedures; date and version of consent form documented; adequate time for participant consideration; re-consent workflow for protocol amendments affecting risk; consent records retained in the TMF with full audit trail; and participant right to withdraw documented. An eConsent platform must create an immutable consent record that satisfies all six requirements without manual reconciliation.
eConsent is the participant-facing workflow for obtaining and documenting informed consent. An eCRF (electronic Case Report Form) is the site-facing instrument for collecting clinical data. Both are governed by ISO 14155:2026, but they serve different functions. The critical compliance requirement is that consent status is traceable to clinical data entry , which requires integration between the eConsent and eCRF environments. MILO Health delivers this integration natively.
MILO Health by Eclevar MedTech is the only eConsent solution built as an integrated module of an EU MDR-native EDC platform. It includes Annex XIV data linkage, ISO 14155:2026 re-consent workflows, GDPR Article 9 architecture, and 21 CFR Part 11 audit trails , all as native features, without custom configuration. It is the only platform that connects eConsent and eCRF in a unified, inspection-ready study environment. Request a live demonstration.
Pages that complement this eConsent guide , from EDC platform selection to full clinical data management.
Top eCRF & EDC Platforms for Clinical Trials in 2026 , EU MDR Edition
electronic informed consent medical devices
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