Swissmedic has published version 6.0 of its technical interpretation on the container-specific guarantee of starting material identity, defining requirements for suppliers, GMP controls, labelling, certificates of analysis and inspections.

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.

The TGA has opened a consultation on proposals to improve public information sharing about the safety, quality and performance of medical devices after post-market reviews or investigations.

A regulatory affairs review highlights how MDSAP methodology can help French and EU medical device manufacturers structure quality management, internal audits and conformity control under the EU MDR.

Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance 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.

NIST AI 600-1 provides a Generative AI Profile for the AI Risk Management Framework, identifying key GAI risks and suggested actions to govern, map, measure and manage them.

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.

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

Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.

European Union publishes Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the EU AI Act to streamline compliance, adjust timelines, and relieve SMEs.

The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.

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.

Swissmedic has updated its checklist for materiovigilance inspections in hospitals, covering medical devices and IVDs, quality management, reporting, traceability, FSN/FSCA processes and staff training.

The MHRA has updated its guidance on the management and use of in vitro diagnostic point-of-care test devices, including POCT services in primary and secondary care settings.

The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.

Swissmedic has updated its information sheet on clinical investigations of medical devices, including approval procedures, ISO 14155, category C investigations, reporting duties and IMDRF adverse event terminology.

The European Commission has published a draft implementing regulation amending common specifications for certain Class D IVDs under the IVDR, including HEV, Toxoplasma gondii, Plasmodium and arboviruses.

Swissmedic has updated its information sheet on IVD performance studies, covering approval procedures, reporting duties, ISO 20916, category C studies and Swissmedic surveillance.

The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.