On April 16, 2024 local time,
01
Security and performance summary template updated
MDCG 2022-9 rev.1-Summary of safety and performance template
Based on the initial version, the template file has made the following revisions, mainly including:
That is
There is not much content in this update, so please pay attention to updating the SSP of existing C/D products according to the above revised content at the same time.
02
Newly published guidance document
MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
The guidance states that the safety reporting of performance studies of in vitro diagnostic medical devices (IVDs) should comply with the requirements of Regulation (EU) 2017/746 Article 76(2):
a) Any serious adverse event that has a causal relationship with the device, comparator device, or study procedure, or there is a reasonably probable causal relationship;
b) any defect in the product that could lead to a serious adverse event if appropriate measures are not taken, or if no intervention is made, or in other adverse circumstances;
c) any new findings relating to any of the events referred to in points a) and b).
MDCG 2024-4 applies to performance studies covered by Articles 58(1), 58(2), 70(1), 70(2) of the IVDR, as well as joint studies of medicinal products and IVDs.
Article 69 of the IVDR stipulates that reports must be submitted in electronic format via EUDAMED.
Due to the imperfection of EUDAMED functionality at this time, this guide outlines the safety reporting procedures in performance studies without EUDAMED.
本指南还定义了严重不良事件（SAE）的报告形式，并提供了一份性能研究安全总结报告模板（Appendix – Performance Study Summary Safety Reporting Form）。
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