Swissmedic has released version 3.0 of its swissdamed Business Rules, effective January 2026. The update includes stricter UDI-DI requirements, limits on legacy device data, and mandatory fields for MDR/IVDR submissions. Manufacturers must now align with Swiss-specific data rules diverging from EUDAMED.

The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.

The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.

The TGA has released an updated consolidated guidance on the Essential Principles for medical devices, outlining key regulatory, safety, and performance requirements manufacturers must meet to supply devices in Australia. This update strengthens expectations for risk management, clinical evidence, design and manufacturing controls, and technical documentation, reinforcing compliance obligations for medical device manufacturers targeting the Australian market.

O novo guia preliminar da FDA sobre UDI em produtos combinados descreve requisitos detalhados para a rotulagem, identificação e submissão ao GUDID. Esta orientação afeta fabricantes de dispositivos médicos e medicamentos combinados, que deverão avaliar se os seus produtos requerem UDI, NDC ou ambos, conforme o tipo de componente principal.