Bringing clarity to medical device regulatory professionals all over the world
The Journal of Medical Device Regulation (JMDR) provides regulatory affairs professionals with the certainty and confidence they need to navigate complex and ever-changing global requirements. It is an indispensable working tool, helping you anticipate regulatory change, understand its impact, and apply it effectively in your daily work to keep your devices compliant and competitive on the world’s markets.
- The impact of halal certification on market access for medical devices in Indonesia – A comprehensive guide for global medical device and IVD manufacturers 9th July 2026 - Understand Indonesia's halal product assurance requirements for medical devices and IVDs, including certification pathways, exemption criteria, and quality management considerations ** Available for pre-order - delivery date 10 August 2026 ** Read More
- A framework for pre-submission risk screening in medical device regulatory submissions: categorising common FDA deficiency themes 9th July 2026 - Learn how a structured framework of 24 common FDA deficiency themes can support more effective pre-submission review for 510(k), PMA, and De Novo applications ** Available for pre-order - delivery date 10 August 2026 ** Read More
- An overview of the medical device regulations in the Arab Republic of Egypt 9th July 2026 - A comprehensive guide to navigating Egypt's evolving medical device regulatory landscape ** Available for pre-order - delivery date 10 August 2026 ** Read More
- Regulatory divergence of NIRS-based technologies: distinguishing cerebral oximeters and fNIRS devices under IEC 80601 standards 5th July 2026 - Understand how evolving IEC standards distinguish cerebral oximeters from fNIRS devices and the implications for regulatory submissions and device classification ** Available for pre-order - delivery date 31 August 2026 ** Read More
- Proposed MDR/IVDR amendments in practice: operational implications for manufacturers 3rd July 2026 - A practical examination of the proposed December 2025 MDR/IVDR amendments and their implications for lifecycle oversight and manufacturer regulatory operations ** Available for pre-order - delivery date 10 August 2026 ** Read More
- Sufficient clinical evidence for medical devices – What is the role of post-market real-world data? 1st June 2026 - This article explores how post-market real-world data (RWD) can support the demonstration of sufficient clinical evidence for medical devices. Read More
- Regulatory Intelligence Pack: AI in MedTech 19th May 2026 - AI-enabled medical devices are now firmly in scope of multiple regulatory frameworks. This Regulatory Intelligence Pack provides a curated set of high-impact AI insights, designed to offer you clarity and practical considerations. Read More
- Use of artificial intelligence in literature screening for regulatory compliance 11th May 2026 - Discover how AI tools can streamline literature reviews for clinical evaluation Read More
- Analysis of the European Commission’s proposal for the revision of the MDR and IVDR 11th May 2026 - A legal analysis of the European Commission proposal and its impact on certification and clinical strategy Read More
- An updated overview of the regulatory requirements for medical devices, including IVDs, in Cuba 11th May 2026 - Get up to speed on Cuba’s latest regulatory developments, including new provisions covering both medical devices and IVDs, and what they mean for market access and compliance Read More
