EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates Manufacturer Responsibility by October 2026

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-09-28

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...