All serious adverse events during a clinical investigation must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed. This concerns all clinical investigations of which the aim is:
- collecting clinical data about a medical device or an AIMD without a CE marking,
- collecting clinical data on a medical device or a CE marked AIMD that is used outside of the CE marking or outside of the intended use provided in the instructions for use of the medical device under investigation.
Adverse events that are identified during a clinical investigation that does not pursue the above objectives and that was not notified to the FAMHP, are defined as adverse reactions, side effects or incidents and must be reported as such in accordance with the applicable materiovigilance procedure.
An adverse event is defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
This definition includes events related to the investigational device or the comparator used in the clinical investigation. This definition includes events related to the procedures involved.
A Serious Adverse Event (SAE) is an adverse event that:
- led to a death, injury or permanent impairment to a body structure or a body function.
- led to a serious deterioration in health of the subject, that either resulted in:
- a life-threatening illness or injury, or
- a permanent impairment of a body structure or a body function, or
- in-patient hospitalization or prolongation of existing hospitalization, or
- in medical or surgical intervention to prevent life threatening illness
- led to foetal distress, foetal death or a congenital abnormality or birth defect.
NOTE : Planned hospitalization for pre-existing condition, or a procedure required by the Clinical Investigation Plan, without a serious deterioration in health, is not considered a serious adverse event.
The timelines for reporting adverse events are described in the guideline.
- Report by the investigator to the sponsor:
Not later than 3 calendar days after the investigational site study personnel’s awareness of the event.
- Report by sponsor to the National Competent Authorities:
- Not later than 2 calendar days after awareness by the sponsor of a new reportable event which indicates an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons
- Not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event of any other reportable events.
Reporting of serious adverse events is not subject to a fee and is therefore free of charge.