European Commission Adopts New Rules for Notified Body Timelines, Quotations and Re-Certification Under MDR and IVDR
The European Commission has adopted Regulation (EU) 2026/977 introducing new MDR and IVDR rules for notified body timelines, quotations, transparency and re-certification activities.
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.
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.
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.
MHRA Updates Guidance on Regulation of Medical Devices in Northern Ireland
MHRA updates guidance on medical device regulation in Northern Ireland. Key impacts for manufacturers under EU MDR and IVDR.
MDCG 2025-10: Strengthened expectations for PMS systems under MDR and IVDR
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.
UK publishes new model periodic safety report (PSUR) for medical devices - MHRA 2024
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.