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New MDCG Guidance documents released: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
- Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
This document provides guidance on the following items:
The reporting methods and format specified in this guidance pertains to the following IVD performance studies:
- All performance studies covered by IVDR Article 58(1) (certain performance studies)
- Performance studies covered by IVDR Article 58(2) (performance studies involving companion diagnostics)
- PMPF studies covered by IVDR Article 70(1) (certain performance study to further assess, within the scope of the intended purpose, a device that is already CE-marked)
- PMPF studies covered by IVDR Article 70(2) (performance study to assess, outside scope of its intended purpose, a device that is already CE-marked)
- Combined studies of medicinal products and IVDs
Definition of terms
A complete overview of terms related to safety reporting of all relevant terms as per IVDR, ISO 20916 and MDCG 2022-10 is given.
Reporting method, what is reportable, report by whom and to whom and reporting timelines, the reporting form template and clarification on how to complete the reporting form.
This document contains detailed guidance on the processing, method, causality determination and timelines to report safety events in IVD performance studies. In the Appendix, the reporting form template for the summary SAE tabulation is provided.
Which events should be reported in IVD performance studies as per IVDR Article 76(2):
- any Serious Adverse Event (SAE) that has a causal relationship with the device, the comparator, or the study procedure or where such causal relationship is reasonably possible;
- any device deficiency that might have led to an SAE if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
- any new findings in relation to any event referred to in points 1) and 2).
From the definition above, it also follows that SAEs related to a CE-marked IVD which is part of a performance study with an IVD for performance evaluation (for example a CE-marked comparator IVD or a CE-marked IVD that is used during the study procedure) are reportable if there is a causal (or reasonably possible) relationship to that IVD. The reporting procedures described in this guide should then be followed by the performance study sponsor, in addition to the normal vigilance reporting for CE-marked devices by the manufacturer (double reporting is certainly possible).
Reporting timelines
The sponsor must report to all NCAs where the PS is authorized to start:
- All reportable events which indicate an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: immediately, but not later than 2 calendar days after awareness by sponsor of a new reportable event or of new information in relation with an already reported event. This includes events that are of significant and unexpected nature such that they become alarming as a potential public health hazard. It also includes the possibility of multiple deaths occurring at short intervals. These concerns may be identified by either the NCA or the sponsor.
- Any other reportable events or a new finding/update to it: immediately, but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or of new information in relation with an already reported event.
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Report by the investigator to the sponsor:
- The sponsor must implement and maintain a system to ensure that the reporting of the reportable events will be provided by the investigator to the sponsor immediately, but not later than 3 calendar days after awareness of the event.
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MDCG 2022-9 Rev.1 Summary of safety and performance Template
IVDR requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public. This revision contains sections for professional and lay users to ensure comprehensibility across audiences. Manufacturers must keep the SSP updated in line with any changes from post-market performance or safety evaluations.
What Does This Mean To You?
MDCG 2024-4 is of relevance to all parties involved in performance studies. This includes IVD manufacturers, performance study sponsors and legal representatives but also pharmaceutical companies conducting combined studies, meaning clinical trials involving a medicinal product under investigation as well as a device for performance study (investigational device).
MDCG 2022-9 Rev1 is of relevance to IVD manufacturers of all class C and D devices as under the IVDR they are required to draw up a summary of safety and performance (SSP).
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