The MDCG (Medical Device Coordination Group) just published a new guidance document on safety reporting in performance studies of in-vitro diagnostic medical devices: MDCG 2024-4. The template of the Summary Reporting Form (MDCG 2022-9) was also just updated.
Article 76 (2) of Regulation (EU) 2017/746 (IVDR) sets the requirements for performance studies of IVD medical devices. A performance study involves one or more subjects to assess the safety or performance of an IVD medical device.
The sponsor, or their legal representative, has to report without delay to all Member States where a performance study is being conducted all of the following:
- any serious adverse event 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 a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
- any new findings concerning any event referred to in points a) and b).
The reporting must occur in electronic format through EUDAMED (IVDR Article 69). As this is not possible yet, this MDCG guidance outlines the safety reporting procedures in performance studies in the absence of EUDAMED.
The different sections of the new MDCG guidance includes, among other things, guidelines on safety reporting, methods, templates, and timelines.
Guidelines on safety reporting
This MDCG guidance document applies to performance studies covered by IVDR Article 58(1), Article 58(2), Article 70(1), Article 70(2), and to combined studies of medicinal products and IVDs. These guidelines can still be relevant for PMPF studies conducted with a CE-marked device used within the intended purpose covered by the CE marking. In this case, this guidance can be used if there is a causal (or reasonably possible) relationship between the serious adverse event and the study. Chapter 10 of MDCG 2024-4 provides further guidelines on how to assess the causality between an IVD medical device use and the occurrence of each serious adverse event.
The events to report are those under IVDR Article 76(2).
Reporting methods, templates, and timelines
In this transitional period to EUDAMED, the following reporting methods apply:
- From 26 May 2022, sponsors have to use the template of the Summary Reporting Form (MDCG 2022-9) for safety reporting, taking into account that also national requirements might apply.
- When EUDAMED is available but not yet mandatory, sponsors have to use either the Summary Reporting Form template or EUDAMED.
- When EUDAMED is mandatory, sponsors have to use EUDAMED, whereas the form can be used only for follow-up reports or final reports to the NCAs on events initially transmitted using the form.
The timelines for reportable events to all national competent authorities are:
- For all events indicating an imminent risk of death, serious injury, or serious illness, and that requires prompt remedial actions or a new finding, the reporting deadline is immediately, but not later than 2 calendar days after awareness by the sponsor of a new reportable event or new information in relation with an already reported event.
- For all other events under IVDR Article 76(2) or events indicating a new finding or update, the reporting deadline is immediately, but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or new information in relation with an already reported event.
Additionally, the sponsor must have a system for reportable events to ensure that the investigator reports the relevant events to the sponsor immediately, but not later than 3 calendar days after awareness of the event.
Among other things, MDCG 2024-4 includes further details on reporting forms, definitions, abbreviations, and casualty assessments.
Check the all guidance on performance studies in our dedicated Library of Documents or contact us for any questions!
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