MHRA Publishes AI Airlock Phase 2 Report on Regulatory Challenges for AI Medical Devices
The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.
MedTech Europe Calls for Clarification on EDPB’s Proposed DPIA Template
MedTech Europe has responded to the EDPB consultation on the proposed DPIA template, calling for greater flexibility and warning against additional compliance burdens for medical device and digital health manufacturers.
European Commission Publishes Third Version of Living Guidelines on the Responsible Use of Generative AI in Research
The European Commission has released Version 3 of its Living Guidelines on the Responsible Use of Generative AI in Research. Learn what the new recommendations mean for medical device manufacturers, clinical evaluation, data protection and research activities.
Swissmedic Highlights Updated MIR Template for Serious Incident Reporting Under MDR/IVDR
Swissmedic highlights the updated MIR template version 7.3.1 for MDR/IVDR vigilance reporting. Learn how the new requirements impact medical device and IVD manufacturers.
FDA Announces New eMDR System Enhancements: What Medical Device Manufacturers Should Know
The FDA has announced new eMDR system enhancements, including AEMS integration updates, country code validation changes, and IMDRF adverse event code updates impacting medical device manufacturers.
European Commission Updates MIR 7.3.1 Vigilance Reporting Forms
The European Commission has updated the MIR 7.3.1 vigilance reporting forms under the EU MDR and IVDR. Manufacturers should verify accepted versions and updated XSD/XSL files.
TEAM-NB Updates Code of Conduct for Notified Bodies (Version 5.2 – April 2026)
TEAM-NB releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.
FDA Updates Coding Resources for Medical Device Reports: Key Changes from IMDRF 2025 Maintenance
FDA updates MDR adverse event codes under IMDRF 2025. Key changes may impact manufacturer reporting, vigilance systems, and data consistency.
MDCG Publishes Revision 2 of EMDN Guidance (MDCG 2021-12 Rev.2)
MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
MDCG Publishes Updated Guidance on Medical Device Classification (MDCG 2021-24 Rev.1)
MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.
FDA Updates eMDR Framework with ESG NextGen Submission Portal
The FDA has replaced the WebTrader system with the ESG NextGen portal for eMDR submissions. Learn what this means for medical device manufacturers and reporting obligations under 21 CFR Part 803.
Swissmedic Updates CAPA Plan Content Requirements for Medical Devices
Swissmedic publishes updated CAPA plan requirements for medical devices, effective April 2026. Key impacts for manufacturers and compliance strategies explained.
Health Canada publishes new guidance on “significant change” for medical devices
Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.
Swissmedic Issues Minor Update to Guidance on User Incident Reporting
Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.
European Commission publishes EUDAMED Release Notes v2.25.2
The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.
Swissmedic Publishes “Good Practice for Materiovigilance in Hospitals” (GPMV-Spital)
Swissmedic releases GPMV-Spital, a new framework for materiovigilance in hospitals. Understand the impact on medical device manufacturers and post-market surveillance.
TGA Publishes Updated Guidance on the Regulation of Software-Based Medical Devices – Key Considerations for Manufacturers
TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.
IMDRF Publishes Final Guidance on the Selection of Adverse Event Terminology
IMDRF publishes final guidance on the selection and consistent use of adverse event terminology (AET) codes for medical devices and IVDs.