The TGA has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests, covering analytical and clinical evidence, self-test usability, IFU requirements, software, COR approvals and post-market monitoring.

The preliminary draft 2027 Annual Union Work Programme for European standardisation includes a standardisation request for medical devices and IVDs under Regulations (EU) 2017/745 and 2017/746.

IMDRF has published its 2026 Document Implementation Report, providing the self-identified implementation status of IMDRF technical documents across member jurisdictions.

The TGA has updated its guidance on clinical performance and risk mitigation requirements for IVD self-tests for chlamydia, gonorrhoea and syphilis, including study design, usability, IFU and post-market monitoring expectations.

Anvisa has published two guidance manuals for the regularization of IVD devices and notification of risk class I and II medical devices, aiming to improve dossier quality and reduce technical requirements and rejections.

EMA has updated its Q&A on practical arrangements for the companion diagnostics consultation procedure by notified bodies, covering letters of intent, IRIS submissions, rapporteur appointment, pre-submission interactions, eSubmission and fees.

Anvisa has announced that registration requests for international manufacturers of risk class I and II medical devices, including IVDs, must now be submitted electronically through the Solicita system using subject code 80326.

Swissmedic has updated its information sheet on procurement of medical devices in healthcare institutions, covering conformity evidence, swissdamed registration, CH-REP and importer information, UDI, implant cards and non-conforming devices.

The EU Commission 20th Notified Body Survey shows a slight decline in MDR applications and continued growth in IVDR applications, highlighting ongoing certification pressures under the MDR and IVDR.

Swissmedic has updated its guidance on export certificates for medical devices, including eligibility, ordering requirements, product lists, CE conformity documentation, swissdamed registration and fees.

The TGA has updated its guidance on how medical device applications are selected for audit before inclusion in the ARTG, including mandatory audits, non-mandatory audit criteria, regulatory reforms, UDI and post-market signals.

Team-NB has presented a proposal for risk-adaptive notified body surveillance under the MDR and IVDR, aiming to reduce unnecessary burden while maintaining patient safety and effective oversight.

FDA updates its list of authorized companion diagnostic devices to 226 entries, covering NGS assays, liquid biopsies, group labeling, and key biomarkers.

MHRA releases its AI Airlock Sandbox Phase 2 report, detailing regulatory insights on AI validation, PCCPs, generative AI, and real-world PMS.

Commission Implementing Decision (EU) 2024/2120 renews the designation of UDI issuing entities for medical devices and IVDs for a further five-year period, until 27 June 2029.

MDCG 2026-5 clarifies that only the manufacturer can assign UDIs to devices placed on the EU market, even where distributors market devices under their own brand.

The European Commission has published Member State summaries of the 2025 annual reports on monitoring and on-site activities regarding notified bodies under the MDR and IVDR.

Swissmedic has updated its information sheet on performance studies of IVDs, covering study categories, approval processes, ISO 20916, reporting duties, safety measures and sponsor obligations.

The MHRA has updated its guidance on registering medical devices, IVDs, custom-made devices, systems and procedure packs for the Great Britain and Northern Ireland markets.

The World Health Organization has published a transitional list of WHO Listed Authorities for medical devices, supporting regulatory reliance for medical devices and IVDs.