The MDCG has published a guidance document concerning safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR. For some background, safety reporting in performance studies of IVD’s shall be performed in line with the requirements of Article 76(2) of the IVDR. According to Article 76(2) of the IVDR, the sponsor shall report the following by means of the electronic system referred to in Article 69 of the IVDR, i.e. EUDAMED 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 in relation to any event referred to in points (a) and (b).
Since the EUDAMED module referred to in Article 69 is not yet available, this guidance intends to outline the procedures needed for safety reporting in performance studies in absence of the EUDAMED module.
The guidance document can be accessed using the following link
