EXPAMED publishes its new Opinion on Performance Evaluation Consultation procedure (PECP)

The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new Opinion in the context of the performance evaluation consultation procedure (PECP) for high-risk IVDs. In the latest Opinion related to a device detecting Hepatitis E virus (HEV) transmission in blood transfusion, the expert panel concluded that:

‘’The evidence provided by the manufacturer was comprehensive, and systematically structured with ease of reference of each document against the relevant clause in Regulation (EU) 2017/746 (IVD Regulation; IVDR). Table 1. “Required Content of the Performance Evaluation Report and Compliance Status” (page . . .

 

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