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.
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.
ANVISA Publishes Draft Normative Instruction on UDI Data Transmission and SIUD Management
ANVISA publishes draft rules on UDI data transmission and SIUD management in Brazil. Learn how the new requirements impact medical device manufacturers.
Swissmedic Updates Formal Requirements Guidance – Version 19.0 Applicable from February 2026
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.
Swissmedic Updates eIAM Portal Administrator Guidance – Version 3.4 Effective February 2026
Swissmedic publishes eIAM Portal Administrator guidance version 3.4, effective February 2026. Learn what this means for manufacturers using Swiss eGov services.
EU-U.S. Data Privacy Framework Updated: What It Means for Medical Device Manufacturers
New EU-U.S. Data Privacy Framework FAQ impacts data transfers to U.S. vendors. What this means for medical device manufacturers in 2026.
Australia Updates Guidance on Export Certificates for Medical Devices: What EU Manufacturers Need to Know
The TGA has updated its guidance on Certificates of Free Sale and Export Certificates for medical devices. Key changes for EU manufacturers exporting via Australia.
ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026
ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.
TGA Updates Guidance on Varying ARTG Entries: Key Points for Medical Device and IVD Manufacturers
The TGA has released Version 6.0 of its ARTG variation guidance. Learn what manufacturers and sponsors need to know to stay compliant with ARTG requirements.