Swissmedic has published Version 21.0 of its Formal Requirements guidance document, introducing updates and clarifications relating to medicinal product authorisation applications, documentation requirements, biosimilars, Article 13 TPA submissions and combination products incorporating medical devices.

FDA has published draft guidance on Forms FDA 3542a and FDA 3542, clarifying requirements for Orange Book patent listings, electronic patent submissions, and the management of patent information throughout the medicinal product lifecycle.

ENISA has published its SBOM Adoption State of Play – 2026 report, providing insights into how organisations across Europe are implementing Software Bills of Materials (SBOMs) in response to the Cyber Resilience Act (CRA) and identifying key challenges affecting adoption.

The Council for International Organizations of Medical Sciences (CIOMS) has published Version 10 of its Glossary of ICH Terms and Definitions, consolidating terminology from current ICH guidelines and supporting greater consistency in regulatory communication across the life sciences sector.

The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.

The EMA has published version 3.6 of its guidance on the implementation of ISO IDMP standards through the Product Management Services (PMS), introducing updates related to data submission, data enrichment, and requirements applicable to marketing authorisation holders.

Health Canada published feedback from its public consultation on Decentralized Clinical Trials, including topics related to digital technologies and data management.

The FDA has updated its draft guidance on medical device manufacturer communications with payors, health economic information, and investigational products.

The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.

The WHO has adopted revised recommendations for International Biological Reference Standards (WHO IBRS), introducing updated guidance on commutability, calibration, secondary standards and International Units. Learn what IVD and biological product manufacturers need to know.

MedTech Europe has published new recommendations for the MDR/IVDR revision, calling for a more proportionate regulatory framework, support for innovation, and improved access to in vitro diagnostics across Europe.

ICH has adopted E6(R3) Annex 2, introducing new Good Clinical Practice guidance for decentralised clinical trials, digital health technologies and real-world data. Learn what it means for medical device manufacturers.

FDA has established a new Class II classification with special controls for transcutaneous electrical nerve stimulators (TENS) intended to treat fibromyalgia symptoms, creating a new regulatory pathway for manufacturers.

Team-NB has published a position paper introducing a template agreement for transferring IVDR applications and legacy device surveillance between notified bodies.

Team-NB has published Version 2 of its MDR Certification Process Consensus Document, providing detailed guidance on pre-application, application, conformity assessment and surveillance activities for medical device manufacturers under EU MDR 2017/745.

The FDA has reported 1,284 Breakthrough Device designations and 198 market-authorised Breakthrough Devices as of March 2026. Learn what this means for medical device manufacturers and U.S. market access strategies.

FDA has updated its guidance on unclassified medical devices, adding five additional device types to its 510(k) enforcement discretion policy. Learn what this means for manufacturers and ongoing FDA compliance obligations.

The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.

The European Commission has released Version 3 of its Living Guidelines on the Responsible Use of Generative AI in Research. Learn what the new recommendations mean for medical device manufacturers, clinical evaluation, data protection and research activities.

The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.