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.

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.

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

FDA has published draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices and combination products. Learn how the recommendations may impact design controls, verification, validation, and change management activities.

MedTech Europe has responded to the EDPB consultation on the proposed DPIA template, calling for greater flexibility and warning against additional compliance burdens for medical device and digital health manufacturers.

Swissmedic has published swissdamed Business Rules Version 4.0, introducing new Master UDI-DI requirements, UDI registration rules, and data management obligations for medical device manufacturers in Switzerland.

The FDA has updated its draft guidance on medical device manufacturer communications with payors, health economic information, and investigational products.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

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.

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 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.

MedTech Europe responds to the EU Cybersecurity Act consultation, highlighting key implications for medical device and IVD manufacturers, including certification, vulnerability management, and supply chain security.

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.

The TGA has updated its guidance on UDI compliance timeframes for medical devices in Australia, including clarifications on legacy devices, EU MDR transitions, consignment stock, and Surgical Loan Kits.

A new legal opinion analyses the European Commission’s proposed MDR Article 50, highlighting potential impacts on notified bodies, SMEs, certification costs, and conformity assessment access.

ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.