Medical Device Coordination Group (MDCG) released a document on 15 April 2024 as per Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European Commission.
This document defines SAE reporting modalities and includes a summary tabulation reporting format.
The reporting modalities and format set out in this guidance apply to:
- Performance studies covered by IVDR Article 58(1):
- • in which surgically invasive sample-taking is done only for the purpose of the performance study;
- • that is an interventional clinical performance study as defined in IVDR Article 2(46);
- • where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies;
- performance studies covered by IVDR Article 58(2) involving companion diagnostics (except when only using left-over samples);
- PMPF studies covered by IVDR Article 70(1) that involve procedures additional to those performed under the normal conditions of use of the IVD and where those additional procedures are invasive or burdensome, in case a causal relationship between a SAE and the preceding performance study has been established;
- performance studies covered by IVDR Article 70(2) that are conducted to assess, outside the scope of its intended purpose, an IVD that already bears the CE marking.
- combined studies of medicinal products and IVDs. When the study satisfies the definition of a performance study of an IVD, regardless of whether it is conducted in the context of a clinical trial of a medicinal product, the requirements of the IVDR and including its safety reporting obligations apply to the study. This guidance document is then relevant for compliance with the IVDR regarding safety reporting. MDCG 2022-10 provides further guidance on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and the IVDR.
As per the document Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR):
The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in IVDR Article 69:
- a) any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such a causal relationship is reasonably possible;
- b) 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;
- c) any new findings in relation to any event referred to in points a) and b).
The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
- For all reportable events as described in section 6 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.
For post-market performance follow-up (PMPF) studies of CE marked devices used within the intended purpose covered by the CE marking, reporting requirements of IVDR Articles 76(5-6) apply. This means that the vigilance provisions laid down in IVDR Articles 82 to 85 and in the acts adopted pursuant to IVDR Article 86 apply to PMPF studies. However, this guidance document is still relevant for PMPF studies as the reporting of serious adverse events (SAEs) where a causal relationship to the preceding PMPF study has been established follow the reporting procedures of performance studies as outlined in IVDR Article 76.
Since the electronic system referred to in IVDR Article 69 (Eudamed and its module for clinical investigations and performance studies) is not yet available and fully functional from the date of application of the IVDR, this guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional.
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