1st December 2025

SafetyEasy® for Medical Device Vigilance

Purpose-Built Vigilance for MedTech Compliance

SafetyEasy® Suite empowers medical device manufacturers, CROs, and regulatory teams to navigate the evolving global safety landscape with confidence. Designed to meet the rigorous demands of EU MDR, FDA regulations, and international post-market surveillance, our platform ensures seamless compliance across the entire device lifecycle. From Class I to III devices and combination products, SafetyEasy® delivers automation, agility, and unified case management—keeping your vigilance operations future-ready and regulation-aligned.

Global Regulatory Readiness for Medical Device Vigilance

Supporting EU MDR, EUDAMED, FDA eMDR, Health Canada, & Combination Product Reporting

Navigating medical device vigilance means staying ahead of evolving regulations across regions. From the EU’s MDR and EUDAMED rollout, to the FDA’s eMDR and combination product guidelines, and now Health Canada’s strengthened post-market surveillance framework, regulatory expectations are becoming more complex and interconnected.

SafetyEasy® Suite is built to meet these challenges head-on—offering pre-integrated reporting formats, automated coding, and seamless updates that ensure your vigilance operations remain compliant, efficient, and future-proof.

EU Regulatory Landscape: MDR, EUDAMED & Vigilance Evolution

Key 2025–2026 Updates:

New MIR Form 7.3.1: Mandatory from November 2025, supporting both PDF and XML formats for digital submissions.
FSCA & MTR Updates: Harmonized Field Safety Corrective Action and Manufacturer Trend Report forms are being finalized with XML compatibility for EUDAMED.
MDCG 2023-3 Rev.2 Guidance: Clarifies definitions of incident vs. serious incident, reporting timelines, and complaint analysis workflows. Aligns with the EUDAMED Post-Market Surveillance and Vigilance module, expected to become compulsory in 2Q27.
PSUR MD Guidance: Periodic Safety Update Reports for medical devices are being standardized under MDCG guidelines, with final revisions expected in 2025.
Gradual Rollout of EUDAMED: The European Commission confirms a phased implementation of the six EUDAMED modules, with full functionality expected by 2026.

SafetyEasy® Suite for EU MDR & EUDAMED Compliance

AB Cube’s platform is engineered to stay ahead of EU regulatory changes, ensuring seamless compliance and operational continuity.

Pre-integrated Reporting Formats: Supports the latest MIR, aligned with MDR Articles 87–89.
XML-Ready Architecture: Fully aligned with the latest available EUDAMED MIR XML specifications, ensuring future compatibility once the final vigilance module is officially implemented.
Embeded IMDRF Coding: Ensures standardized terminology and faster processing.
Validated Compliance Framework: Built to meet GAMP®5, EU MDR, and GDPR standards.
EUDAMED-Ready Architecture: SafetyEasy® Suite is continuously updated to reflect new MDCG guidance and EUDAMED module rollouts—no disruption, no revalidation needed.
Multivigilance Integration: Seamlessly manages device vigilance alongside pharmacovigilance, cosmetovigilance, and nutrivigilance in one platform.

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U.S. FDA: eMDR & Combination Product Reporting

Key 2025–2026 Updates:

eMDR Enhancements: By March 31, 2025, manufacturers must comply with new eMDR requirements, including:
- Mandatory weight unit fields if weight is reported
- Complete adverse event coding using IMDRF and FDA MDR AE codes
- Submissions missing these elements will be rejected with an Ack 3 error
Combination Product Reporting: The FDA’s guidance enables unified safety submissions for products combining drug, biologic, and device components. This introduces E2B(R3) as the new standard format.
E2B(R3) Implementation: Full compliance with E2B(R3) for combination products will be required by March 2026.

SafetyEasy® Suite for FDA Compliance:

AB Cube’s platform is engineered to stay ahead of regulatory changes, ensuring seamless compliance and operational continuity.

Supports Combination Product Safety Reporting: SafetyEasy® Suite enables unified reporting workflows for combination products, aligned with FDA’s evolving standards.
E2B(R3)-Ready Architecture: Our software has been updated in 2025 to fully support E2B(R3) submissions ahead of the April 2026 mandate
Pre-integrated Reporting Formats: Includes eMDR, MedWatch, and both E2B(R2) and E2B(R3) PV Formats.
Embeded Adverse Event Coding: Built-in support for IMDRF and FDA MDR AE dictionaries ensures accurate and compliant submissions.
Validated Compliance Framework: Fully aligned with GAMP®5, FDA 21 CFR Part 11, and GDPR.
Seamless Regulatory Updates: All enhancements are deployed without disruption—no costly revalidations or manual upgrades.

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Canada: Strengthening Post-Market Surveillance

Key 2024–2025 Updates:

Mandatory Shortage & Discontinuation Reporting: As of April 17, 2025, Health Canada expanded the list of medical devices subject to mandatory reporting under Sections 62.23 to 62.25 of the Medical Devices Regulations. Manufacturers and importers must report shortages and discontinuations of specified devices.
Modernized Recall Framework: New regulations coming into force on December 14, 2024, redefine “recall,” establish a framework for minister-ordered recalls, and clarify industry obligations for voluntary recalls. These updates align Canadian practices with international standards.
Expanded Surveillance Powers: Health Canada has implemented new post-market surveillance authorities under Vanessa’s Law, including powers to require safety assessments, tests, and studies. These changes enhance lifecycle oversight and risk management.