Fact Sheet
Understanding Key Safety and Clinical Performance Regulations for Medical Devices
Comprehensive regulatory support to drive medtech innovation forward
Nov 03, 2022
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The Summary of Safety and Clinical Performance (SSCP) is a requirement imposed by the European Commission in Medical Device Regulations (MDR) 2017/745 for implantable devices and class III devices, other than custom-made or investigational devices.

IQVIA MedTech takes pride in its proven track record with regulatory document preparation and regulatory authority submissions in varied therapeutic areas. Backed up by years of experience and an extensive knowledge of the EU MDR, IQVIA MedTech can help you prepare an entire portfolio of documents including but not limited to clinical evaluation plans, clinical evaluation reports, and summary of safety and clinical performance.

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