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.

FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.

New Team-NB position paper clarifies IVDR expectations for safety, risk assessment and performance evaluation of reagent devices used in combination.

The European Commission adopts Implementing Decision (EU) 2026/193, updating harmonised standards under MDR (EU) 2017/745.

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.

ANVISA publishes draft rules on UDI data transmission and SIUD management in Brazil. Learn how the new requirements impact medical device manufacturers.

The FDA has published a draft guidance adopting the ICH E22 guideline on Patient Preference Studies. Learn what this means for manufacturers involved in global development programmes.

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.

Swissmedic has published version 19.0 of its Formal Requirements Guidance, applicable from February 2026. Learn what manufacturers and combination product developers need to prepare for.

The FDA has issued an updated guidance on Computer Software Assurance for production and quality management system software, aligned with the new QMSR and ISO 13485.