Recording and reporting of adverse events and device defects that occur during CI
It is the sponsor's responsibility to establish, in a protocol, the definitions of serious adverse events and device defects, identifying those that may be critical to the clinical investigation (CI), and to determine the procedures and deadlines for such information to be communicated to them by the investigators, allowing them to comply with the obligations set out in Article 80 of Regulation (EU) 2017/745.
Investigators, in compliance with the clinical investigation plan and good clinical practices, must notify the sponsor of critical adverse events in the plan, serious adverse events, and device defects when they become aware of them. While no specific deadline is foreseen, through MDCG 2020-10, the European Commission, together with the Competent Authorities, recommends that safety information be communicated to the sponsor as soon as possible, not exceeding 3 calendar days.
Adverse events considered critical for the evaluation of results and identified in the clinical research plan, serious adverse events, device defects that could have led to a serious adverse event if adequate measures had not been taken, if an intervention had not been performed, or if circumstances had been less favorable, and new data on these events, must be fully recorded by the sponsor.
The sponsor must submit the cumulative safety report with a compilation of the recorded data and a critical analysis whenever such information is requested by the competent authority.
Notification to INFARMED, I.P.
The notification of safety information must follow the terms established in Article 80 of Regulation (EU) 2017/745.
From the universe of recorded information, the sponsor notifies INFARMED, I.P. and the competent authorities of all Member States involved, without delay, and taking into account the severity:
- any serious adverse event that has a causal relationship with the experimental device, comparator or research procedure or where such a causal relationship is reasonably possible;
- device defects that could have led to a serious adverse event if appropriate measures had not been taken, if an intervention had not been carried out or if the circumstances had been less favourable; and
- new data on such events.
Through MDCG 2020-10, the European Commission, together with the Competent Authorities, recommends that, in the case of serious adverse events that pose an imminent risk of death, serious injury or serious illness and that require immediate corrective action, the sponsor's communication to the Member States should occur immediately, not exceeding 2 calendar days. Other types of reportable adverse events, namely those relating to device defects that could have led to a serious adverse event, and new data relating to any event, must be reported to Infarmed and the competent authorities of all Member States involved. In those cases, immediate communication is recommended, not exceeding 7 calendar days from the moment the sponsor became aware of them.
The notification must use the tabular format for reporting serious adverse events or device defects annexed to MDCG 2020-10/1 - Guidance on safety reporting in clinical investigations, accompanied by the relevant documentation.
Until EUDAMED is operational in Portugal, the submission of any safety notification must be done through the RNEC.
PMCF Investigations
It is important to emphasize that, in the case of Post-Marketing Clinical Follow-up (PMCF) investigations, the notification requirements within the national medical device vigilance system must be essentially met. Questions regarding the rules and operation of the Surveillance System may be addressed to the Medical Devices Vigilance Unit (UVD) via the email address dvps@infarmed.pt.
In PMCF investigations, whenever a causal link is established between a serious adverse event and the preceding experimental procedure, such events must also be notified, in accordance with Article 80 of Regulation (EU) 2017/745, to the Authorities within the scope of the clinical investigation, using the tabular format for reporting serious adverse events and device defects annexed to MDCG 2020-10/1 - Guidance on safety reporting in clinical investigations, to INFARMED, I.P.
