EUDAMED Deadline 2026: What to Do Before 27 November
September 28, 2026
Your devices have been on the EU market for years. They have valid certificates, a technical file and
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
Your devices have been on the EU market for years. They have valid certificates, a technical file and
Generative AI medical devices are moving into a new regulatory phase. In its 2026 discussion paper, the FDA
ANVISA has opened a new opportunity for manufacturers of innovative medical devices seeking a clearer regulatory path in
Learn more about the FDA’s regulatory framework for AI-powered medical devices and other global recent updates.
In the development and approval process of medical devices, three types of evaluations frequently appear in regulatory requirements:
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements
While the FDA strengthens cosmetic recalls, the EU and China are making important regulatory updates.
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
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