MDN is a weekly digest covering selected regulatory updates, standards developments, official communications, guidance documents, recalls, and institutional news related to the medical device and in vitro diagnostic (IVD) sector.

The newsletter focuses on relevant updates published by major regulatory and institutional sources, including:

• European Commission
• MDCG
• FDA
• EUDAMED
• Team-NB
• MHRA
• IMDRF

Each issue is designed to provide a concise overview of the most relevant weekly developments affecting the medical device regulatory and standards landscape.

Topics covered may include:

• MDR / IVDR updates
• MDCG guidance documents
• FDA safety communications
• Recalls and vigilance updates
• Cybersecurity and medical software developments
• EUDAMED developments

MDN is intentionally concise and designed to be read in just a few minutes.

MDN uses AI-assisted monitoring to help identify potentially relevant updates from official regulatory and institutional sources. Selected items are reviewed against the original source before publication. Readers should always refer to the official documentation for complete and authoritative information.

The content is provided for informational purposes only and does not constitute regulatory, legal or professional advice.