European Stakeholders Call for a Single Regulatory Pathway for AI-Enabled Medical Technologies
European healthcare and industry organisations are calling for AI-enabled medical devices and diagnostics to be regulated through a single MDR/IVDR pathway integrating relevant AI Act requirements.
ISO October 2026 Update Highlights Key Medical Device and IVD Standards
The ISO October 2026 update highlights new and developing standards covering sterilization, medical device packaging, implants, catheters, IVDs, NGS workflows, rapid diagnostics and health informatics.
TGA Updates Guidance on Clinical Decision Support Software Regulation
TGA has updated its guidance on Clinical Decision Support System software, clarifying when CDSS is excluded, exempt from ARTG inclusion or subject to full medical device regulation in Australia.
MHRA Updates Medical Device Registration Guidance for Great Britain and Northern Ireland
MHRA has updated its medical device registration guidance, clarifying registration requirements, DORS fees, Northern Ireland obligations, importer information and post-market responsibilities.
WHO Sets 2030 Strategy to Detect Emerging Health Threats Within 24 Hours
WHO’s Pandemic and Epidemic Intelligence Hub has launched its 2026–2030 strategy, aiming to detect and understand new health threats within 24 hours through stronger surveillance, AI, genomics and digital intelligence.
Swissmedic Updates eMessage Functions for Medical Device Regulatory Correspondence
Swissmedic has updated its eMessage functions information sheet, clarifying electronic submissions, responses, acknowledgements, inbox management and digital signatures for medical device regulatory correspondence.
MHRA Updates Real-World Evidence Guidance for Medicines and Medical Devices
MHRA has updated its Real-World Evidence knowledge and guidance resource, covering regulatory standards, RWD quality, clinical studies, post-market use, scientific advice and support for medicines and medical devices.
FDA Issues Guidance on Postapproval Manufacturing Changes for Biosimilars
FDA has issued final guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products, covering reporting categories, comparability, CMC data and new dosage forms or strengths.
FDA Seeks OMB Clearance to Continue MedSun Medical Device Adverse Event Surveillance
FDA has submitted the MedSun adverse event information collection program for OMB review, supporting continued surveillance of medical device deaths, serious injuries and malfunctions through approximately 300 participating facilities.
FDA Expands CDRH Learn With New UDI and Biocompatibility Training Modules
FDA has expanded CDRH Learn with new October 2026 modules covering Unique Device Identification and extraction approaches for chemical analysis in medical device biocompatibility assessment.
FDA Highlights Extraction Approaches for Biocompatibility and Chemical Characterization Testing
FDA’s September 2026 Town Hall focused on extraction approaches for chemical characterization testing under ISO 10993-18 and common issues in medical device biocompatibility assessment.
Health Canada Updates Medical Device Shortage and Discontinuation Reporting Guidance
Health Canada has issued Version 4 of GUI-0137, updating requirements for reporting medical device shortages and discontinuations and providing shortage-related information under the Medical Devices Regulations.
Swissmedic Updates Hospital Materiovigilance Inspection Checklist for Medical Devices and IVDs
Swissmedic’s updated hospital materiovigilance inspection checklist covers quality management, incident reporting, FSN and FSCA handling, traceability, UDI and staff training for medical devices and IVDs.
UK Government Accepts All 44 Recommendations on AI Regulation in Healthcare
The UK Government has accepted all 44 recommendations from the National Commission on AI in Healthcare, setting out a roadmap for lifecycle regulation, PCCPs, post-market oversight, cybersecurity and clearer pathways for AI-enabled medical devices.
Health Canada Implements Updated Bioequivalence and Biowaiver Evaluation Templates
Health Canada has implemented updated Version 2 templates for bioequivalence and BCS-based biowaiver submissions, aligned with ICH M10, M13A and M9.
Anvisa Publishes Implementation Plan for ICH E8(R1) and E6(R3) Guidelines
Anvisa has published its implementation plan for ICH E8(R1) and E6(R3), outlining a gradual approach to applying updated principles for clinical studies and Good Clinical Practice in Brazil.
MHRA Updates Safety Guidelines for MRI Equipment in Clinical Use
MHRA’s fifth edition of its MRI safety guidelines provides updated recommendations on MR hazards, governance, controlled access, implants, pregnancy, exposure, training, equipment lifecycle and incident reporting.
FDA List Highlights Authorized Companion Diagnostic Devices and Group Labeling
FDA’s companion diagnostic device list includes 232 authorized IVD and imaging entries, with group labeling approaches for oncology therapies and a new 2026 melanoma CDx authorization.
EU Expert Panel Raises Clinical Evidence Concerns for Bioabsorbable Orthopaedic Screws
An EU CECP Expert Panel has issued a scientific opinion on Class III bioabsorbable orthopaedic screws, identifying gaps in clinical evidence, benefit-risk assessment and PMCF planning.