There is a new IVDR MDCG guidance published MDCG 2024-4 Safety Reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746, with a publish date April 2024. Performance studies are performed to confirm the analytical or clinical performance of an IVD.
Key Highlights:
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- Performance studies covered by IVDR Article 58(1) and 58(2)
- PMPF (post market performance follow-up) studies covered by Article 70(1)
- Performance studies covered by Article 70(2)
- Combined studies of medicinal products and IVD’s
According to Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation, (a) any serious adverse event that has a causal relationship with the device, comparator or the study procedure, (b) a device deficiency that might have led to a serious adverse event or any new findings in relation to any event in both (a) and (b) shall be reported in EUDAMED (Article 69 or IVDR).
What does this new guidance document do?
Due to the fact EUDAMED is not fully functional, this new guidance outlines the procedures for safety reporting in performance studies. The guidance informs sponsors about the acceptable formats used when reporting to the Competent Authorities, types of reportable events, who should report and to whom, the reporting timelines, causality assessment, and instructions on how to fill in the reporting form available in the appendix of the guidance document.
You can read the entire guidance document here.
MDCG 2022-9 Rev.1 Safety and Performance Update
The guidance changes include clarification on when the summary of safety and performance should be made available to patients, a change in the layout information in the information summary for patients/lay persons, wording has changed – ‘intended use of the device’ replaced by ‘intended purpose and other indications’.
You can read the updated document here.
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If you need assistance in understanding the new guidance document or minor safety and performance update, please contact us so we can help you.