MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.

EU expert panel highlights clinical evidence gaps, benefit-risk concerns and PMCF weaknesses for bioabsorbable orthopaedic screws under MDR.

Swissmedic updates guidance on systems and procedure packs. Key obligations, CH-REP requirements, and impact for medical device manufacturers.

The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.

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 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.

Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.

FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.

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 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 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 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 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.

IMDRF releases its 2026 Playbook for Medical Device Regulatory Reliance Programs, outlining work-sharing, recognition and abridged pathways.

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 Version 1.0 of the swissdamed Machine-to-Machine REST API documentation for UDI registration and market status management.

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 Great Britain and Northern Ireland. Key rules on UKCA, CE marking and registration.

MHRA updates UK medical device registration rules, introduces annual Level 2 GMDN-based fees from April 2026 and confirms NI EUDAMED transition.