Regulatory information for medical devices and IVDs

MDN – Medical Device News, MDR Navigator and the MDR/IVDR Resources are informational tools designed to help follow regulatory updates and navigate regulations, guidance documents and official sources.

MDN is a free weekly newsletter dedicated to regulatory updates relevant to medical devices and IVDs.

It brings together a selection of official communications, guidance documents, recalls and institutional news, summarised clearly and linked to the original source.

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Ogni lunedì alle 15:00, ora italiana.

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Resources and Insights

A new section of the website dedicated to introductory guides on the MDR and IVDR, references to official sources, and articles covering key regulatory developments in the medical device industry, both in Europe and internationally.

MDR Navigator

An informational AI-based assistant that allows users to ask questions in natural language about the MDR, IVDR and MDCG guidance documents.

It is designed to facilitate the consultation of regulatory content and provide a first general orientation within the European medical device regulatory framework.

The content published on this website, including newsletters, articles, guides and informational tools, is provided for informational purposes only and does not constitute regulatory, legal, technical or professional advice. For complete and up-to-date information, refer to official sources, the applicable documentation and, where necessary, qualified professionals. The images featured on this website are for illustrative purposes only and may have been generated or edited with the support of artificial intelligence tools.