Insights into MDR SSCP requirements.
The Summary of Safety and Clinical Performance (SSCP) is a new requirement under the European Medical Devices Regulation 2017/745 (EU MDR), applicable to Class III and implantable devices. It summarizes the evidence for the safety, performance and clinical benefit of the device in light of its intended purpose, and places this in the context of outcomes achievable with other diagnostic or therapeutic alternatives for the same patient population.
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