ANVISA Updates Manual for Medical Device Registration in Brazil
Brazil’s health authority ANVISA has released the revised 2025 edition of its Manual for the Registration of Health Products, incorporating key regulatory updates for medical device manufacturers. The manual reflects the latest changes under RDC No. 751/2022, RDC No. 848/2024, and RDC No. 556/2021, offering clear guidance on classification, technical dossiers, and grouping rules. This update is essential for any manufacturer placing medical devices on the Brazilian market.
MDCG 2025-8: New Guidance on Master UDI-DI Implementation for Spectacles and Highly Individualised Devices
The new MDCG 2025-8 guidance provides detailed rules for manufacturers on how to implement the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. Covering UDI assignment, design parameter grouping, EUDAMED registration and vigilance obligations, this document is essential for manufacturers of highly individualised devices seeking MDR compliance and improved traceability.