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 [email protected]. Explore our free AI tools and device database at https://pureglobal.ai.