A TGA publicou um guia atualizado sobre cibersegurança em dispositivos médicos. Conheça os requisitos regulamentares, boas práticas e responsabilidades dos fabricantes para proteger a segurança do doente e a integridade dos sistemas de saúde.

Version 7.3.1 of the MIR form, published by the European Commission on June 4, 2025, introduces new requirements for reporting serious incidents involving medical devices and IVDs.

The new edition of the IMDRF Operating Procedures (Edition 13, 2025) clarifies the mechanisms for joining, developing and managing technical and regulatory documents in the medical devices sector. This document reinforces IMDRF's role in international harmonization, with a direct impact on the predictability of the rules applicable to manufacturers. The participation of regulatory authorities and industry stakeholders in these processes makes it possible to align technical requirements with global principles of compliance, safety and performance.

The IMDRF has published a Playbook for the evaluation of Artificial Intelligence and Machine Learning (AI/ML) medical devices, addressing safety, efficacy and regulatory requirements. Global harmonization of these medical devices is essential to ensure transparency, reliability and compliance.

The IMDRF has released the 2025 update of the terminology for Reporting Adverse Events in Medical Devices, which includes new terms, modifications and removals in various annexes of the document. This revision aims to standardize and improve the reporting of adverse events, so that a globally harmonized classification is used to report and investigate incidents related to medical devices.