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MDR | IVDR | SSCP Requirements | Safety and Performance (SSP)

Overcoming Challenges and Streamlining Your SSCPs and SSPs

In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are finding it challenging to produce these reports because they are completely new to everybody. 
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Safety and Performance (SSP)

An Overview of Summary of Safety and Performance (SSP) Under IVDR

EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized data on safety and performance to intended users, which includes both professionals and laypeople when applicable.
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