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 releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.

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, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

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 publishes updated CAPA plan requirements for medical devices, effective April 2026. Key impacts for manufacturers and compliance strategies explained.

Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.

Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.

The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.

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 software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.

IMDRF publishes final guidance on the selection and consistent use of adverse event terminology (AET) codes for medical devices and IVDs.

The TGA updated its PRAC recall procedure in February 2026. Here’s what medical device and medicine manufacturers must know about compliance and market actions in Australia.

Swissmedic has published version 1.2 of its guidance on the Medical Device Publication Service, clarifying how Field Safety Corrective Actions and Field Safety Notices are published and accessed.

New MDCG guidance on post-market surveillance provides clearer operational expectations for manufacturers under MDR and IVDR. PMS plans must now be more proactive, structured, and integrated into the QMS.

Swissmedic’s updated guidance on PSUR Signal Management sets a higher standard for pharmacovigilance in Switzerland. By aligning with EU Regulation 2019/6 and VICH GL 29, it requires manufacturers to strengthen PSUR reporting, signal evaluation, and safety data traceability. For medical device and IVD producers, this shift underscores the importance of robust post-market surveillance and regulatory readiness. Smart MDR supports companies in navigating these evolving frameworks efficiently and confidently.

The MHRA has published a new Periodic Safety Update Report (PSUR) template for medical devices in the UK, in line with the UK MDR. The document details how manufacturers should structure their post-market monitoring (PMS) reports, including performance data, surveillance, PMCF and benefit-risk profile analysis.

Version 7.3.1 of the MIR form, published by the European Commission on June 4, 2025, introduces new requirements for reporting serious incidents involving medical devices and IVDs.