Medical Device Global Market Access

EU AI Act & Medical Devices: Deadline Extended to 2028 for High-Risk Systems

The European Union has extended the compliance deadline for the AI Act for high-risk medical devices and IVDs already regulated by the MDR and IVDR. A provisional agreement on the Digital Omnibus package has postponed the application date by two years to August 2, 2028. This episode explores what this delay means for manufacturers, how it impacts compliance strategies, and the practical steps regulatory and quality teams should take to prepare for the eventual implementation. Key Questions: - What is the new AI Act compliance deadline for high-risk medical devices? - How does the Digital Omnibus package affect MDR and IVDR manufacturers? - Why was the original 2026 deadline for the AI Act extended? - What does this extension mean for your AI governance and QMS integration strategy? - Should you pause your AI Act compliance activities because of the delay? - How do the requirements of the AI Act and the MDR/IVDR overlap? - What practical steps should regulatory teams take over the next two years? - How will harmonized standards for AI in medical devices evolve before 2028? Sources: - https://www.medtech-europe.org/news/medtech-europe-reaction-to-the-provisional-agreement-on-the-digital-omnibus-on-ai/ - https://www.morganlewis.com/pubs/2026/05/recent-eu-and-uk-medical-devices-developments-eu-mdr-ivdr-eu-ai-act-uk-medical-devices-regime - https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/ How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative in over 30 markets. Our experts help you navigate complex requirements like the EU AI Act and MDR/IVDR, ensuring your products remain compliant from initial registration through post-market surveillance. Leverage our advanced AI tools and global expertise to accelerate your market entry. Visit us at https://pureglobal.com, contact us at info@pureglobal.com, and explore our free AI tools and database at https://pureglobal.ai.

FDA 510(k) Exemption Guidance 2026: Five New Product Codes Exempted

The US FDA issued a final guidance on June 4, 2026, immediately exempting five unclassified medical device product codes from 510(k) premarket notification requirements. This episode details the guidance, 'Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements,' explaining which manufacturers are affected, the scope of the FDA's enforcement discretion, and the critical regulatory obligations—like QMSR, registration, and listing—that remain in effect. We outline practical steps for regulatory teams to adapt their market access strategies in response to this change. Key Questions: - What is the new FDA guidance issued on June 4, 2026? - Which types of medical devices are now exempt from 510(k) notification? - Is this 510(k) exemption effective immediately? - Does this exemption mean manufacturers can ignore all FDA regulations? - What are the remaining obligations, such as QMSR and device listing? - How does this change the market access pathway for these specific devices? - What immediate steps should regulatory teams take in response to this guidance? - How can companies verify if their product code is on the new exemption list? Sources: - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/intent-exempt-certain-unclassified-medical-devices-premarket-notification-requirements - https://www.federalregister.gov/documents/2026/06/05/2026-11303/intent-to-exempt-certain-unclassified-medical-devices-from-premarket-notification-requirements - https://www.raps.org/news-and-articles/news-articles/2026/6/fda-to-exempt-five-more-unclassified-devices-fr How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex regulatory landscapes and accelerate market access. Our experts develop efficient regulatory strategies and use advanced AI to compile and manage technical submissions for authorities like the US FDA. We can help you understand the impact of new guidance, update your compliance framework, and ensure all requirements beyond 510(k) exemption, such as QMSR and registration, are met. For support with your US market access strategy, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI regulatory tools and device database at https://pureglobal.ai.

China NMPA's New Dynamic Medical Device Classification: What Manufacturers Need to Know

This episode explores the China NMPA's new dynamic adjustment procedure for its Medical Device Classification Catalog, effective June 1, 2026. We discuss what this shift from a static to an evolving system means for manufacturers, including the impact of announcements No. 52 and No. 53, and the new obligation to continuously monitor for changes that could affect regulatory pathways, timelines, and costs for market access in China. Key Questions: - What is the NMPA's new dynamic adjustment procedure for medical device classification? - When did this new Chinese regulation take effect? - How do announcements No. 52 and No. 53 of 2026 change the classification process? - Why must manufacturers now continuously monitor the NMPA's classification catalog? - What are the risks if my device is reclassified from Class II to Class III? - How can a change in classification impact my market access strategy in China? - What practical steps can my regulatory team take to stay compliant? - How should we update our QMS to address this new requirement? Sources: - https://vcbeat.top/89484/ How Pure Global can help: Navigating dynamic regulatory landscapes like China's NMPA is critical for market success. Pure Global helps MedTech and IVD companies streamline global market access with end-to-end consulting. Our experts develop efficient regulatory strategies, manage technical dossier submissions using advanced AI, and act as your local representative in over 30 markets. We provide continuous regulatory monitoring to ensure your products remain compliant with evolving rules, like the new NMPA classification procedure. To secure and maintain your market presence in China and beyond, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

EU Notified Body Timelines: New MDR & IVDR Rules for Predictable CE Marking

The European Commission has adopted Implementing Regulation (EU) 2026/977, establishing harmonized and binding timelines for Notified Body conformity assessments under the MDR and IVDR. This episode details the new maximum timelines for key review stages—such as the 90-day limit for technical documentation assessment—and new rules for cost transparency. We explore how this regulation, adopted on May 4, 2026, provides greater predictability for manufacturers in their CE marking process, addressing long-standing industry concerns about inconsistent and lengthy review periods. Key Questions: - What is EU Implementing Regulation 2026/977 and why was it created? - What are the new maximum timelines for Notified Body conformity assessments under the MDR and IVDR? - How does the 90-day limit for technical documentation review impact CE marking strategy? - What do the new rules on cost transparency mean for manufacturers? - How can manufacturers leverage these changes to improve their product launch planning? - What happens if a manufacturer's submission is incomplete and the review clock is stopped? - How should regulatory teams adjust their internal processes in response to this regulation? - What are the key obligations for Notified Bodies under these new rules? Sources: - https://www.medtecheurope.org/news-and-events/news/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/ - https://www.jdsupra.com/legalnews/recent-eu-and-uk-medical-devices-8924156/ - https://www.decomplix.com/medical-device-regulatory-affairs-news/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies navigating complex global markets. We help manufacturers adapt to new requirements like the EU's harmonized Notified Body timelines by developing efficient regulatory strategies and preparing high-quality technical dossiers to avoid delays. Our combination of local experts in over 30 markets and advanced AI technology streamlines the submission process, ensuring your products get to market faster. For support with your CE marking strategy or global expansion, visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.

UK MHRA Draft 2026 Medical Device Regulations: International Reliance and What's Next

The UK's MHRA has published draft medical device regulations set for 2026, introducing a new standalone framework for Great Britain. This episode breaks down the most significant change: the International Reliance pathway, which will leverage approvals from the US, Canada, and Australia to streamline UK market access. We cover the critical June 19, 2026, deadline for the industry impact survey, other key changes like UDI implementation and new rules for software, and provide practical steps for manufacturers to prepare for this new era of UK medical device regulation. Key Questions: - What is the new International Reliance pathway proposed by the UK MHRA? - Which international approvals will be recognized under the new UK framework? - What is the deadline for submitting feedback on the draft 2026 regulations? - How will the new rules affect software as a medical device (SaMD)? - What is the role of the UKCA mark in this new reliance model? - Who is affected by these proposed regulatory changes? - What practical steps should manufacturers take to prepare for 2026? - How will the introduction of a UDI system impact device traceability in the UK? Sources: - https://www.hoganlovells.com/en/publications/uk-medical-devices-reform-mhra-publishes-draft-2026-regulations-and-launches-impact-survey - https://www.jdsupra.com/legalnews/recent-eu-and-uk-medical-devices-8991557/ - https://www.nsf.org/knowledge-resources/mhra-reform-2026-new-requirements-medical-devices-great-britain - https://www.arnoldporter.com/en/perspectives/publications/2026/05/mhra-publishes-draft-amendment-to-the-uk-medical-devices-regulations - https://www.pinsentmasons.com/out-law/analysis/update-to-the-medical-devices-regulatory-regime-key-proposals-and-implications How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to navigate complex market changes like the UK's new 2026 regulations. Our experts develop efficient regulatory strategies, act as your local UK Responsible Person, and use advanced AI to compile and manage technical dossiers for UKCA submissions. We help you leverage the new International Reliance pathway by assessing your existing approvals and streamlining your path to market. Whether you're a startup or a multinational, we accelerate your access to over 30 global markets. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.