FDA has published draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices and combination products.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The FDA has updated its draft guidance on medical device manufacturer communications with payors, health economic information, and investigational products.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.

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.

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 FDA has released a major update to its Bioequivalence Statistical Guidance, replacing the 2001 version. The new document introduces adaptive designs, modern statistical methods, guidance for highly variable drugs, NTI products, missing data handling and model-based approaches for generic drug development.

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.