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.

The MHRA has updated its guidance on clinical investigations for medical devices, including applications, assessment timelines, amendments, reporting requirements and fee waiver information.

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

The CD-P-TO has published a position paper on the MDR and its implications for the substances of human origin sector, focusing on Article 5(5), RUO products and CE-marked devices used beyond their intended purpose.

Swissmedic has updated its swissdamed User Guide for the UDI Devices Module, including guidance on UDI registration, market status, M2M, Master UDI-DI and legacy devices.

The European Commission has published the 20th Notified Body survey results under the MDR and IVDR, with data status 28 February 2026.

FDA has updated its technical specifications guidance on submitting next-generation sequencing protocols, data and analyses to the Division of Antivirals.

NIST has published a news release on a mathematical proof supporting the transition from a “one and done” AI security model to continuous monitoring and updating.

The European Commission has published the third EO survey results on the availability of medical devices and IVDs on the EU market, with data status 31 October 2025.

Team-NB has published a proposal for a risk-adaptive surveillance system under the MDR, covering surveillance audits, unannounced audits, technical documentation sampling and PSUR updates.

The TGA has updated its guidance on regulatory requirements for Ahpra-registered dental practitioners making or adapting personalised medical devices for patients.

The FDA has announced upcoming eMDR system enhancements, including AEMS consolidation, country code requirements and IMDRF adverse event code updates.

The MHRA has published a paper on regulatory-grade data, real-world data and the data infrastructure needed to support safety surveillance and regulatory decision-making.

Team-NB has published a proposal for a risk-adaptive surveillance system under the IVDR, covering surveillance audits, unannounced audits and technical documentation sampling.

The TGA has updated its guidance on how medical device and IVD applications are selected for audit before inclusion in the ARTG.

Anvisa has published technical documentation supporting the integration of electronic prescription systems with the SNCR, including API specifications, technical requirements and developer guidance.

The European Commission has published an unofficial consolidated version of the AI Act incorporating the Digital Omnibus amendments, providing an updated reference for manufacturers and other stakeholders.

MHRA guidance on medical device borderlines in Great Britain, covering intended purpose, UKCA scope and manufacturer considerations.

Anvisa has announced the permanent discontinuation of the Sicert Medical Device Certificate Issuance System, completing the transition to the new certificate generation tool integrated into the Solicita System.