EU MDCG 2026-4: SSCP Upload to EUDAMED for Class III & Implantable Devices

This episode covers the EU's new MDCG 2026-4 guidance, which transfers the responsibility for uploading the Summary of Safety and Clinical Performance (SSCP) from Notified Bodies to manufacturers. We discuss the impact on manufacturers of Class III and implantable devices, the key deadline of February 2027 for uploading the SSCP to EUDAMED, and the practical steps regulatory and quality teams must take to ensure compliance with this significant procedural change. Key Questions: - What is the major change introduced by MDCG 2026-4? - Who is now responsible for uploading the Summary of Safety and Clinical Performance (SSCP) to EUDAMED? - Which device classes are affected by this new guidance? - What is the deadline for manufacturers to upload the SSCP for existing devices? - When will the new EUDAMED functionality for manufacturer uploads be available? - How should manufacturers coordinate with their Notified Bodies for the validated SSCP? - What internal procedures need to be updated to comply with this change? - Why is this shift in responsibility significant for regulatory teams? - What are the first steps your company should take to prepare for the February 2027 deadline? Sources: - https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping them navigate complex requirements like the EU MDR and new MDCG guidance. We act as a local representative, develop regulatory strategies, and use advanced AI to compile and manage technical dossiers for EUDAMED submissions. Our experts can help you update your quality management system and internal procedures to comply with the new SSCP upload requirements, ensuring a smooth transition and continued market access in the EU. For support, contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.