Recording, reporting and evaluating side effects during clinical trials on drugs and after the drugs’ marketing authorisation is imperative for the safety of patients. With medical devices, too, patient safety has priority. Unlike with drugs, though, the safety of users and third parties is also recorded here. This article shall highlight the differences between an incident and a serious adverse event as well as provide information on reporting requirements and timelines.
Even when a medical device has been carefully constructed, manufactured and tested, damage might still occur from time to time. If a defect of the device is considered the cause of a serious deterioration of a patient’s or user’s state of health, this is called an “incident”. In accordance with the German Medical Devices Safety Plan Ordinance (MPSV) § 2 paragraph 1, an incident is defined as “any operational problem, any failure or change in the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use which has led, could have led, or might possibly lead, directly or indirectly, to the death or serious deterioration in the state of health of a patient, user or other person.”
The Medical device safety and the protection of the health of patients, users and other persons is governed inter alia by the German Act on Medical Devices (MPG). In order to identify any unexpected risks arising from medical devices early on, device manufacturers as well as operators, users and the persons responsible for placing the device on the market (physicians, dentists, therapists, pharmacists) have a notification obligation. Any incident must be reported immediately in Germany and the notification must be made electronically to the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (PEI) by the persons responsible. The competent authority then transfers the incident report to the manufacturer. The latter has to issue a statement concerning the incident which illustrates the corrective actions that have been taken.
Examples of incidents that must be reported:
- Mechanical problems (e.g. broken electrodes, catheters, implants)
- Electrical defects (e.g. short circuit, electric shock, power supply failure, early battery depletion)
- Inaccurate labelling or instructions for use (e.g. missing warning notices)
- Measurement errors (e.g. inaccurate scale markings on syringes).
Serious Adverse Event (SAE):
Where clinical data from literature, from clinical experience or from previously conducted clinical trials are not sufficient to assess the safety and/or the performance of a medical device, a clinical trial will be conducted. If serious adverse events occur during a clinical trial or performance evaluation, they must be reported by the sponsor to the competent higher federal authority (BfArM or PEI) in accordance with MPSV § 3 paragraph 5 in Germany.
A serious adverse event is defined as “any untoward event that occurs during a clinical trial or performance evaluation requiring approval, which has led, could have led or might possibly lead, directly or indirectly, to the death or serious deterioration in the state of health of a subject, user or another person, whether or not the event is related to the medical device” (MPSV § 2 paragraph 5).
In Germany, the investigator must report any SAE to the sponsor immediately according to MPSV § 3 paragraphs 4 through 6. The sponsor in turn is responsible for immediately notifying the competent higher federal authority (BfArM or PEI) of all serious adverse events, even if they occurred outside of Germany. If the SAE also constitutes an incident, i.e. there was, or could have been, a causal relationship between the SAE and the medical device, an incident report must be made to the higher federal authority in addition to the SAE report.
Since 29 July 2014, all serious adverse events that occurred at German investigational sites and that do not constitute incidents are comprehensively documented by the sponsor and reported to the competent authority in summary form at quarterly intervals or upon request if “a causal relationship between the SAE and the investigational medical device, a comparator device, diagnostic or therapeutic procedures performed as part of the clinical trial or other conditions of the trial conduct can be excluded” (MPSV § 5 paragraph 2). The sponsor must conduct the investigations necessary for their risk assessment and then inform the higher federal authority of the results. SAE summary evaluations must be prepared at regular intervals containing a benefit-risk assessment of all SAEs occurred since the start of the trial.
Are you conducting a medical device trial in Germany? The MEDICRO Vigilance Team will gladly assist you in meeting all reporting requirements on time. For more information, do not hesitate to contact us.