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| skip to Main Content Menu Buy Subscription My Account Get Alerts Help Contact * What’s New * Shopping Basket * Checkout * Shop + Subscription + Single Issues + Digital Bookstore * Services + Free Sample + Download Brochure + Email Alerts * Resources + JMDR Issue Headlines + Podcasts * About JMDR + Introduction + Editorial Board + Write For Us + News & Press Releases + Advertise + Testimonials * Need Help? + Subscriber Login + FAQs + Contact Us * Shop 0 * Search Search Submit Basket Our Latest Publication: November 2025 – Volume 22, Issue 4 View Publication Home * Shopping Basket * Checkout Shop * Subscription * Single Issues * Digital Bookstore Services * Free Sample * Download Brochure * Email Alerts Resources * JMDR Issue Headlines * Podcasts About JMDR * Introduction * Editorial Board * Write For Us * News & Press Releases * Advertise * Testimonials Need Help? * Subscriber Login * FAQs * Contact Us * Facebook * LinkedIn * Youtube * RSS Welcome to the Journal of Medical Device Regulation 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. * We have a new CORE: a subscription licence for 2 people 25th November 2025 - We are pleased to announce the launch of our new CORE licence - a new subscription type designed specifically for compact regulatory teams who need access for two professionals. Over the past year, many readers told us that their regulatory teams… Read More * Media Guide for 2026 11th November 2025 - Now Available: 2026 Media Guide from Global Regulatory Press Download your copy of our 2026 Media Guide from our “Advertise” webpage. Why advertise with the JMDR? The JMDR reaches one of the most specialised professional audiences in the global medtech… Read More * Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program 10th November 2025 - Discover how to strategically secure breakthrough device designation through proven approaches and practical insights from FDA experience Read More * Navigating UDI compliance in the EU: Practical approaches for complex and special device categories 10th November 2025 - Learn actionable strategies for managing UDI for complex and special device classifications while maintaining regulatory efficiency Read More * Spotlight on recent regulatory changes in South Africa 10th November 2025 - Understand South Africa’s evolving medical device framework and its implications for registration, compliance, and market entry Read More * The EU Data Act – how manufacturers lose control over connected device data 10th November 2025 - Prepare for the EU Data Act: explore how new data access and sharing obligations transform connected device governance and reshape manufacturers’ control of data Read More * Converging regulations: the EU’s WFD, SCIP reporting, the ESPR, and the future of sustainable medical device design 10th November 2025 - Navigate the intersection of safety and sustainability and uncover how converging EU environmental regulations will redefine product design and compliance strategies Read More * Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications 10th November 2025 - Strengthen cybersecurity compliance and apply the NIST SSDF framework to build secure, risk-appropriate development processes for medical device software Read More * Regulatory Monitor – updating you on legislative changes 10th November 2025 - Get the latest international regulatory updates from the JMDR November 2025 issue - concise, expert-curated updates to keep you ahead in the medical device industry Read More * FREE webinar recording: The UKCA – Now, Next, Navigating Ahead 4th November 2025 - The UKCA marking continues to reshape market access in the UK. In this free-to-watch webinar, Teresa Perry of Peritus Regulatory Consulting Ltd explains where the UKCA framework stands today and what changes are on the horizon, as well as offering… Read More Home | Subscribe | My Account | Privacy Policy | T&Cs | Site Map | Contact Us © Copyright Global Regulatory Press 2004 - 2026. All rights reserved. ISSN 1759-149X This website uses cookies to improve your experience but you can opt-out if you wish. AcceptReject Read More Close Privacy Overview This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience. Necessary Necessary Always Enabled Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information. SAVE & ACCEPT Back To Top | skip to Main Content Menu Buy Subscription My Account Get Alerts Help Contact * What’s New * Shopping Basket * Checkout * Shop + Subscription + Single Issues + Digital Bookstore * Services + Free Sample + Download Brochure + Email Alerts * Resources + JMDR Issue Headlines + Podcasts * About JMDR + Introduction + Editorial Board + Write For Us + News & Press Releases + Advertise + Testimonials * Need Help? + Subscriber Login + FAQs + Contact Us * Shop 0 * Search Search Submit Basket Our Latest Publication: November 2025 – Volume 22, Issue 4 View Publication Home * Shopping Basket * Checkout Shop * Subscription * Single Issues * Digital Bookstore Services * Free Sample * Download Brochure * Email Alerts Resources * JMDR Issue Headlines * Podcasts About JMDR * Introduction * Editorial Board * Write For Us * News & Press Releases * Advertise * Testimonials Need Help? * Subscriber Login * FAQs * Contact Us * Facebook * LinkedIn * Youtube * RSS Welcome to the Journal of Medical Device Regulation 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. * We have a new CORE: a subscription licence for 2 people 25th November 2025 - We are pleased to announce the launch of our new CORE licence - a new subscription type designed specifically for compact regulatory teams who need access for two professionals. Over the past year, many readers told us that their regulatory teams… Read More * Media Guide for 2026 11th November 2025 - Now Available: 2026 Media Guide from Global Regulatory Press Download your copy of our 2026 Media Guide from our “Advertise” webpage. Why advertise with the JMDR? The JMDR reaches one of the most specialised professional audiences in the global medtech… Read More * Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program 10th November 2025 - Discover how to strategically secure breakthrough device designation through proven approaches and practical insights from FDA experience Read More * Navigating UDI compliance in the EU: Practical approaches for complex and special device categories 10th November 2025 - Learn actionable strategies for managing UDI for complex and special device classifications while maintaining regulatory efficiency Read More * Spotlight on recent regulatory changes in South Africa 10th November 2025 - Understand South Africa’s evolving medical device framework and its implications for registration, compliance, and market entry Read More * The EU Data Act – how manufacturers lose control over connected device data 10th November 2025 - Prepare for the EU Data Act: explore how new data access and sharing obligations transform connected device governance and reshape manufacturers’ control of data Read More * Converging regulations: the EU’s WFD, SCIP reporting, the ESPR, and the future of sustainable medical device design 10th November 2025 - Navigate the intersection of safety and sustainability and uncover how converging EU environmental regulations will redefine product design and compliance strategies Read More * Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications 10th November 2025 - Strengthen cybersecurity compliance and apply the NIST SSDF framework to build secure, risk-appropriate development processes for medical device software Read More * Regulatory Monitor – updating you on legislative changes 10th November 2025 - Get the latest international regulatory updates from the JMDR November 2025 issue - concise, expert-curated updates to keep you ahead in the medical device industry Read More * FREE webinar recording: The UKCA – Now, Next, Navigating Ahead 4th November 2025 - The UKCA marking continues to reshape market access in the UK. In this free-to-watch webinar, Teresa Perry of Peritus Regulatory Consulting Ltd explains where the UKCA framework stands today and what changes are on the horizon, as well as offering… Read More Home | Subscribe | My Account | Privacy Policy | T&Cs | Site Map | Contact Us © Copyright Global Regulatory Press 2004 - 2026. All rights reserved. ISSN 1759-149X This website uses cookies to improve your experience but you can opt-out if you wish. AcceptReject Read More Close Privacy Overview This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. 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