FDA updates SOPP 8412 on product labeling review
FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.
MDCG 2025-8 Rev.1: Guidance on Master UDI-DI for Spectacle Devices
MDCG 2025-8 Rev.1 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.
European Reference Networks Continue to Expand: What It Means for Medical Device Manufacturers
Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.
FDA Publishes Updated Guidance on Pyrogen and Endotoxins Testing
FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.
FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The FDA has issued final guidance on medical devices with indications associated with weight loss, outlining regulatory expectations for clinical studies, non-clinical testing, and benefit-risk evaluation.
Swissmedic Updates “Formal Requirements” Guidance – Version 20.0 Now in Force
Swissmedic has released Version 20.0 of its “Formal Requirements” guidance, effective 1 March 2026. Learn what pharmaceutical manufacturers need to know about submission formats, documentation requirements and parallel import updates.
Swissmedic Updates swissdamed UDI Data Dictionary
Swissmedic has published version 3.0 of the swissdamed UDI Data Dictionary, introducing clarifications to SRN fields and new machine-to-machine attributes for improved data mapping.
Team-NB Raises Concerns Over Proposed MDR and IVDR Revision
Team-NB warns that proposed MDR and IVDR revisions could reduce regulatory scrutiny and create unintended consequences for EU manufacturers, despite improvements in digitalisation and innovation pathways.
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.
IMDRF Publishes 2026 Playbook for Medical Device Regulatory Reliance Programs
IMDRF releases its 2026 Playbook for Medical Device Regulatory Reliance Programs, outlining work-sharing, recognition and abridged pathways.
TGA Updates PRAC Guidance: What Sponsors and Manufacturers Need to Know in 2026
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 Publishes swissdamed Machine-to-Machine REST API Documentation (Version 1.0)
Swissmedic publishes Version 1.0 of the swissdamed Machine-to-Machine REST API documentation for UDI registration and market status management.
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.
MHRA Updates Guidance on Regulating Medical Devices in the UK
MHRA updates guidance on regulating medical devices in Great Britain and Northern Ireland. Key rules on UKCA, CE marking and registration.
MHRA Updates Guidance on Registration of Medical Devices for the UK Market
MHRA updates UK medical device registration rules, introduces annual Level 2 GMDN-based fees from April 2026 and confirms NI EUDAMED transition.
FDA Updates Recognized Biocompatibility Standards – Recognition List No. 065
FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.
Team-NB Publishes New Position Paper on Safety and Performance of Reagent Devices Used in Combination
New Team-NB position paper clarifies IVDR expectations for safety, risk assessment and performance evaluation of reagent devices used in combination.
European Commission Publishes Updated Harmonised Standards Under MDR
The European Commission adopts Implementing Decision (EU) 2026/193, updating harmonised standards under MDR (EU) 2017/745.
MHRA Publishes Updated Guide on Defective Medicinal Products
The MHRA has published its February 2026 Guide on Defective Medicinal Products. Learn what UK manufacturers and marketing authorisation holders must do regarding defect reporting, recalls, and DMRC obligations.