Episode Details

This episode covers the significant procedural change announced in MDCG 2026-4, where medical device and IVD manufacturers will now be responsible for uploading the Summary of Safety and (Clinical) Performance (SSCP/SSP) to the EUDAMED database. We explain how this shifts the task from Notified Bodies to manufacturers of Class III, implantable, and Class C/D IVD devices, effective with the launch of new EUDAMED functionality in October 2026. The host details the practical implications and provides actionable steps for regulatory and quality teams to prepare for this mandatory handover. Key Questions: - What is the MDCG 2026-4 position paper and how does it change EUDAMED uploads? - When will manufacturers be required to upload the SSCP and SSP to EUDAMED themselves? - Which device classes are affected by this new EUDAMED responsibility? - What will the Notified Body's role be after this change takes effect in October 2026? - How does this shift impact the overall EUDAMED compliance workflow? - What are the first steps to prepare our team for direct EUDAMED submissions? - How should we update our Quality Management System (QMS) for this new requirement? - Why is the European Commission making this change? - What happens if the uploaded SSCP/SSP is not validated by the Notified Body? Sources: - https://www.meddeviceguide.com/en/meddevice-blog/mdcg-2026-4-eudamed-sscp-ssp-upload How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We help you navigate complex requirements like the EU MDR, IVDR, and the EUDAMED database. Our experts can develop your regulatory strategy, prepare technical dossiers, and act as your local representative in over 30 markets. By combining in-country expertise with advanced AI tools, we ensure your submissions are efficient and compliant, helping you maintain market presence and adapt to changes like the new SSCP/SSP upload process. Visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai to learn more.