MTI roundup of global medical device regulatory news

EU Commission Updates

EUDAMED modules confirmed fully functional – Use Timeline and 2026 Deadline

(Actors Registration, UDI Device Reg., Certificates, Market Surveillance), a key milestone toward wider MDR/IVDR compliance and transparency. The European Commission has officially confirmed that several key electronic systems within the European Database on Medical Devices (EUDAMED) are now fully functional and meet the functional specifications required under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This confirmation was published on 27 November 2025 through Commission Implementing Decision (EU) 2025/2371, marking a major milestone in the progressive rollout of the EU’s digital regulatory framework for medical devices and IVDs. Read more at MedEnvoy

New measures to make EU health sector more innovative, competitive and resilient

The European Commission has today proposed an ambitious package of measures to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the health sector. The package includes a Biotech Act, revised rules for medical devices, and a Safe Hearts Plan…Read more at European Commission

Commission promises ‘interesting reading’ ahead of medical device rules overhaul

The European Commission is preparing to unveil a major overhaul of the EU’s medical device rules on 16 December, with officials promising “interesting reading” before Christmas as Brussels moves to correct what it now sees as an overly complex and unevenly applied framework…Read more at EU Perspectives

FDA Regulatory Guidance & Initiatives

Final FDA guidance on Real-World Evidence (RWE) for medical devices

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled “Use of Real- World Evidence to Support Regulatory Decision-Making for Medical Devices.” FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” issued August 31, 2017, and provides expanded and updated recommendations. Read more at GovInfo

FDA announced the “TEMPO” digital health devices pilot program

The FDA announces the “Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,” in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety. The FDA will collect statements of interest for participation in the TEMPO pilot beginning January 2, 2026…Read more at U.S. Food and Drug Administration

The QMSR Transition, New FDA Guidance, and Their Impacts on Active Implantable Medical Devices 

On February 2, 2026, FDA will transition the existing Quality System Regulation (QSR) defined in 21 CFR 820 to the Quality Management System Regulation (QMSR). The current good manufacturing practices in the QSR will be amended to align more closely with international regulations by incorporating by reference ISO 13485:2016, “the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.” Read more at FDLI

Canadian Updates

Medical Devices updates: Phase II consultation on Medical Devices Regulations amendments, medical device licences guidance and IMDRF table of contents guidance

Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, modernizing medical device establishment license (MDEL) application requirements, and granting the Minister of Health authority to issue terms and conditions on an MDEL. Additionally, Health Canada issued new guidance for managing applications for medical device license and adoption of International Medical Device Regulators Forum (IMDRF) table of contents, which will take effect on February 2, 2026…Read more at JD Supra

Australia/Pacific

Australia and Indonesia achieve WHO Listed Authority status in medical products regulation

Australia’s Therapeutic Goods Administration (TGA) and The Indonesian Food and Drug Authority achieve listings to mark a milestone for regulatory excellence and expand access to safe, quality-assured medical products worldwide…Read more at World Health Organization

Japan’s national standard for Electromagnetic Compatibility (EMC) alignment with IEC grace period ends February 2026

JIS T 0601-1-2 is Japan’s national standard for Electromagnetic Compatibility (EMC) of medical electrical equipment, aligning with the international IEC 60601-1-2 standard, which sets requirements for safety and essential performance in electromagnetic environments; the latest Japanese revision, JIS T0601-1-2:2023, incorporates the latest IEC updates (like Amendment 1:2020) and provides a grace period for compliance until February 2026, ensuring devices function safely amidst interference…Read more at Qualtech