Report of serious adverse events
The investigator must report to the sponsor immediatly (no later than two days) not to exceed 3 calendar days from the time of becoming aware of all serious adverse events, as well as device defects that may have led to a serious adverse event.
Any type of serious adverse event must be fully recorded and reported by the sponsor to INFARMED, I.P. and to the competent authorities of all Member States concerned, immediately and not later than two days from the moment of becoming aware of it.
The other types of reportable adverse events, namely those related to device defects that may have led to a serious adverse event or new information in relation with an already reported event, should also be recorded and notified to INFARMED, I.P. and the competent authorities of all Member States concerned, immediately, not exceeding 7 calendar days, counted from the date of awareness by the sponsor.
The sponsor must also notify the annual cumulative safety report, compiling the gathered data and a critical analysis, whenever such information is requested by the competent authority.
Notification to INFARMED, I.P.
For clinical investigations of devices, recording and reporting of serious adverse events and device defects shall follow the terms agreed in Article 80 of Regulation (EU) 2017/745.
In reporting, the tabular format for reporting serious adverse events or device defects attached to MDCG 2020-10 / 1- Guidance on safety reporting in clinical investigations, accompanied by relevant documents, should be used.
Until the operationalization of EUDAMED in Portugal, the submission of any security notification must be made through the RNEC.
Circular Informativa N.º 006/CD/550.20.001 de 21/06/2021 - Aplicação do Regulamento dos Dispositivos Médicos (RDM) na parte que se refere à investigação clínica de dispositivos.
It should also be noted that, in the case of PMCF investigations referred to in Article 74(1), the manufacturer must guarantee that when a serious adverse event that occur in Portugal regarding which there is a suspect of relationship to the device (i.e. meets the criteria of notification via Vigilance System) is individually notified to the Vigilance Unit of Infarmed using the appropriate European harmonized template as per MEDDEV 2.12/1 rev.8 guideline (Guidelines on a Medical Device Surveillance System).
All relevant documentation can be submitted to Infarmed by contacting email@example.com (Health Products Surveillance Unit).
In the case of PMCF investigations referred to in Article 74(1), where a causal relationship between the serious adverse event and the preceding investigational procedure has been established, such occurrences must additionally be notified in accordance with Article 80 of Regulation (EU) 2017 / 745, used for this 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, IP.