SSCP

This page provides access to the Summary of Safety and Clinical Performance (SSCP) for applicable implantable and Class III devices, made publicly available in accordance with Regulation (EU) 2017/745 (MDR). The SSCP is intended to support transparency by presenting a high-level summary of the device’s safety, clinical evaluation and performance, and relevant residual risks and warnings, as assessed within the conformity assessment process. It is not a substitute for the Instructions for Use (IFU) or professional medical judgement. Always follow the IFU and consult a qualified healthcare professional for clinical decision-making.

For Summary of Safety and Clinical Performances (SSCP), please contact qm@aditus-medical.de