EU MDR Well-Established Technologies (WET) Exemption: New Rules for Class III and IIb Devices

EU MDR Well-Established Technologies (WET) Exemption: New Rules for Class III and IIb Devices

The European Commission has significantly expanded the list of 'well-established technologies' (WET) under the EU Medical Devices Regulation (MDR) as of June 29, 2026. This episode details the two new Delegated Regulations, explaining how this change exempts dozens of additional Class III and implantable devices—including certain catheters, bone fillers, and spinal fixation systems—from the default requirement to conduct clinical investigations. We explore the practical implications for manufacturers, including how to leverage this exemption to save time and resources, what kind of evidence is required for justification, and how it streamlines conformity assessment for certain Class IIb devices. Key Questions: - What are 'well-established technologies' (WET) under the EU MDR? - Which new device types were added to the WET list on June 29, 2026? - How does the WET exemption affect clinical investigation requirements for Class III devices? - What does the updated rule mean for conformity assessment of Class IIb implantable devices? - Can manufacturers of newly listed WET devices avoid conducting new clinical trials? - What kind of evidence is needed to justify using the WET exemption? - How should you update your Clinical Evaluation Report (CER) for a WET device? - What are the immediate next steps for manufacturers of devices like spinal fixation systems or dental implants? - How should you approach discussions with your Notified Body about this change? Sources: - https://www.raps.org/news-and-articles/news-articles/2026/6/european-commission-expands-list-of-well-established-technologies-under-mdr - https://www.qbd.group/en/news/new-mdr-updates-for-well-established-technologies/ - https://www.emergobyul.com/news/wet-devices-legally-expanded-european-legislation - https://www.citeline.com/insights/eu-expands-mdr-wet-exemption-list How Pure Global can help: Pure Global provides expert regulatory consulting for MedTech and IVD companies navigating complex regulations like the EU MDR. Our team can help you determine if your device qualifies under the new Well-Established Technologies (WET) exemption, develop a robust clinical evaluation strategy, and compile the necessary technical documentation to justify your approach to Notified Bodies. By combining local expertise with advanced AI, we streamline your path to market access, saving you time and resources. For end-to-end support on regulatory strategy, dossier submission, and post-market compliance, visit us at https://pureglobal.com or contact us at info@pureglobal.com. Explore our free AI tools and device database at https://pureglobal.ai.

China NMPA BCI Classification Guidance: A New Framework for Neurotech Devices

China's National Medical Products Administration (NMPA) has released its first-ever "Guiding Principles for the Classification of Brain-Computer Interface (BCI) Medical Devices" on June 30, 2026. This episode breaks down the new framework, explaining how the NMPA now classifies invasive and non-invasive BCI technologies based on risk and intended use. We cover the implications for manufacturers, detailing the pathways for Class II and Class III devices and providing actionable steps for regulatory, quality, and market-access teams to prepare for submission in China. Key Questions: - What are China's new classification rules for Brain-Computer Interface (BCI) devices? - How does the NMPA distinguish between invasive (Class III) and non-invasive (Class II/III) BCI technologies? - What makes a non-invasive BCI device Class II versus Class III under the new guidance? - What are the immediate steps foreign neurotech manufacturers should take to comply with Announcement No. 24? - How will this new framework affect the timeline and cost for BCI market entry in China? - What kind of clinical evidence will be required for high-risk BCI devices? - Why is a product's intended use now the most critical factor for BCI device classification in China? Sources: - https://www.jdsupra.com/legalnews/china-clarifies-medical-device-8356947/ How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies seeking to enter complex markets like China. Our local experts and advanced AI tools streamline the entire market access process, from developing a regulatory strategy aligned with new guidance like the NMPA's BCI framework to compiling technical dossiers and managing submissions. We act as your local representative, ensuring ongoing compliance and post-market surveillance. Leverage our expertise to navigate the specific requirements for innovative devices and accelerate your product's journey to market. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.

FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032

The US FDA has announced a public meeting on July 22, 2026, to discuss the proposed recommendations for the sixth reauthorization of the Medical Device User Fee Amendments (MDUFA VI). This episode breaks down the MDUFA framework, explores the key proposed changes for fiscal years 2028-2032, and analyzes the impact on manufacturers. We cover potential changes to submission review timelines, new initiatives for digital health and AI/ML devices, and the expected adjustments to user fees, providing practical steps for regulatory teams to prepare. Key Questions: - What is MDUFA and why is its reauthorization critical for device manufacturers? - What are the key proposed changes for MDUFA VI covering fiscal years 2028-2032? - How might new performance goals impact 510(k) and PMA review timelines? - What new initiatives for digital health and AI/ML devices are being considered? - When is the public meeting and how can manufacturers provide input? - What are the potential financial implications of the proposed user fee structure? - How does MDUFA VI aim to enhance the pre-submission and post-market processes? - What practical steps should regulatory teams take now to prepare? Sources: - https://www.federalregister.gov/documents/2026/07/07/2026-14531/medical-device-user-fee-amendments-public-meeting-request-for-comments - https://www.fda.gov/news-events/cdrh-new-news-and-updates/july-7-2026-register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex regulatory landscapes like the MDUFA reauthorization. Our experts develop efficient market access strategies, manage technical dossier submissions, and provide continuous regulatory monitoring to ensure your products remain compliant. By combining local expertise in over 30 markets with advanced AI tools, we streamline the registration process, saving you time and resources. Whether you're a startup or a multinational, we can help you prepare for MDUFA VI and accelerate your global expansion. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting

On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy NOTIVISA platform. This episode details the critical changes, including the adoption of the International Medical Device Regulators Forum (IMDRF) adverse event coding, which aligns Brazil's technovigilance requirements with global standards. We discuss the implications for manufacturers and Brazil Registration Holders (BRHs) and provide practical steps for updating quality systems, training teams, and ensuring compliance with the new structured data requirements. Key Questions: - What is the new e-Notivisa system launched by Brazil's ANVISA? - When did the e-Notivisa system become mandatory for adverse event reporting? - How does e-Notivisa change technovigilance requirements in Brazil? - What are the key differences between e-Notivisa and the old NOTIVISA system? - How does the adoption of IMDRF adverse event codes impact manufacturers? - Why is this new system important for global regulatory harmonization? - What immediate actions should manufacturers and Brazil Registration Holders take? - How should quality and regulatory teams update their procedures for the new system? Sources: - https://www.emergobyul.com/news/brazil-anvisas-new-e-notivisa-system-major-shift-medical-device-vigilance How Pure Global can help: Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in Brazil and over 30 other markets, managing post-market surveillance and ensuring compliance with evolving regulations like ANVISA's e-Notivisa system. Our experts can help update your QMS, train your team on IMDRF coding, and manage all submissions to keep your products on the market. Leverage our local expertise and advanced AI tools to navigate complex regulatory landscapes efficiently. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

Brazil ANVISA Regulatory Reliance: IN 290/2024 Changes for Class III & IV Devices

Brazil's ANVISA has implemented a more flexible amendment process for its regulatory reliance pathway for high-risk medical devices under Normative Instruction 290/2024. Effective June 2026, this change allows ANVISA to issue questions and request revisions for Class III and IV device submissions based on approvals from Comparable Foreign Regulatory Authorities (AREEs), rather than issuing an outright rejection for minor issues. This episode details the new interactive process, who is affected, and the practical steps manufacturers should take to leverage this more efficient pathway to the Brazilian market. Key Questions: - What is Brazil's new regulatory reliance process under IN 290/2024? - How does this change affect Class III and IV medical device manufacturers? - Which foreign regulatory approvals are recognized by ANVISA for this pathway? - What was the old submission process, and why is the new one more efficient? - How can manufacturers avoid outright rejection of their reliance submissions? - What practical steps should regulatory teams take to adapt to this change? - When did this new, more flexible process become effective? - Does this change reduce the documentation requirements for ANVISA submissions? Sources: - https://www.emergobyul.com/news/regulatory-reliance-authorizations-brazils-revised-anvisa-process-june-2026 How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a combination of local expertise and advanced AI. Our team helps you navigate complex landscapes like Brazil's ANVISA requirements, from initial regulatory strategy and technical dossier preparation to post-market surveillance. We act as your local representative in over 30 markets, using a single, efficient process to unlock multiple regions. Leverage our free AI tools and extensive device database at https://pureglobal.ai to accelerate your research, or contact us at info@pureglobal.com and visit https://pureglobal.com to learn how we can get your product to market faster.