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

ANVISA has launched a public call for contributions to support the revision of Brazil's medical device vigilance regulatory framework, seeking feedback from medical device registration holders on post-market surveillance requirements and future regulatory developments.

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.

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.

TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.

ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

Did you miss our holiday announcement? Don't worry—there is still time to accelerate your market entry in 2026 with an exclusive advantage. Regulatory compliance shouldn't be a barrier to innovation. At Smart MDR, we are extending our special support for Startups to ensure your medical device, IVD, or SaMD hits the European market faster and more efficiently.

A TGA australiana publicou um guia atualizado sobre a regulamentação de software e IA com fins médicos. Descubra os requisitos de conformidade, riscos e oportunidades para fabricantes e desenvolvedores de dispositivos médicos digitais.

The proposed revision of IEC 62304 brings important changes for the development of software for medical devices and other healthcare applications. The new version expands the concept of Health Software to include solutions that assist in health management and monitoring, even without being classified as medical devices. Among the main changes are the simplification of the classification of software rigor, the removal of specific Quality System requirements and the revision of Risk Management, which no longer requires ISO 14971. In addition, the approach to legacy software will be reformulated, with guidelines transferred to an informative annex. As this update is still in the proposal stage, manufacturers should keep an eye on the changes and prepare for future adaptations.