All Medical Devices Regulation (MDR) articles
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Industry newsEuropean Commission targets high-risk AI with new draft guidelines
The European Commission has published draft guidelines to help developers determine whether their artificial intelligence (AI) qualifies as ‘high-risk’ under Article 6 of the AI Act. For developers of AI-enabled medical devices, the stakes are particularly high.
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ContentsRegulatory Rapporteur May 2026 – Contents
The May issue of Regulatory Rapporteur focuses on careers.
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Journal2025 UK MDR Regulatory Conference: Meeting report
This article is a report of the 2025 UK MDR Regulatory Conference that was hosted by TOPRA and RAPS.
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Industry newsEC proposes regulation to simplify rules on medical and in vitro diagnostic devices
This industry news update shares the EC’saim to simplify medical and IVD device rules through a new proposal.
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ContentsRegulatory Rapporteur December 2025 – Contents
The December issue of Regulatory Rapporteur focuses on North America.
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ContentsRegulatory Rapporteur November 2025 – Contents
The November issue of Regulatory Rapporteur reports on sessions from the TOPRA Symposium 2025.
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JournalSandbox of trust: Regulated AI for health promotion and disease prevention
This article explores the capacity and potential for AI tools in analysing health data and helping with disease prevention.