What is it? Why is it important?
- Is a system for monitoring risks related to the use of market approved Medical Devices (MD)
- Is a duty of any healthcare professionals prescribing / giving / using marketed MDs
- Is required for category A and post-market stage studies, as these studies investigate market approved MDs
The aim is to protect patients and users of market approved MDs (e.g. MD with CE markings) by:
- Monitoring the occurrence or reoccurrence of incidents
- Improving the quality of MDs and thereby increasing safety
- Withdrawing dangerous MDs from the market
MDs are classified into different categories (e.g. based on invasive or non-invasive MDs, according to various risk categories such as a higher risk for implantable MDs). Each category requires different assessment procedures for market approval. A successful MD compliance assessment results in a so-called CE marking (Conformité Européenne). With this label the MD can be placed on the market.
What do I need to do?
As a SP-INV and Site-INV familiarise yourself with safety reporting requirements of category A studies, to which MV reporting applies. Thus safety reporting procedures include:
- Requirements defined in ClinO-MD
- MV reporting to Swissmedic regarding the occurrence of serious incidents in Switzerland (SADE, DD with SADE potential)
Report serious incidents using the form provided on the Swissmedic website:
- Immediately but not later than 2 days: in the event of a recall (e.g. the MD is removed from the market as it is defective or / and a risk to health, serious public health threat)
- Within 10 days: in the event of a fatal event, or an unanticipated serious deterioration in state of health of a study participant, MD user, or other person
- Within 15 days: regarding other serious incidents (e.g. labelling inadequacy that might lead to a serious incident)
In addition, through the MV system also inform the MD marketing holder about any serious MD incidences.
A hospital is legally obliged to set up a MV reporting system. A designated hospital staff is responsible to manage MV reports and notify Swissmedic of any serious incidences.
Definition of serious incidence:
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.
Examples of reportable incidents include:
- A patient dies following the use of a defibrillator. There is a reason to believe that the defibrillator did not perform as intended.
- An infusion pump stops unintentionally without issuing an alarm
- A user finds glass particles in a contact lens container bottle
- A patient suddenly experiences severe pain in the area of his/her hip implant. An x-ray reveals that the implant is broken and no longer correctly integrated with the bone (connection with medical device). Revision surgery is required (serious deterioration in the state of health)
- An elastomeric pump with a cancer therapy drug empties too quickly, although the dosage and quantity of the drug in the pump was correctly calculated (event in connection with medical device). Fortunately, the patient does not subsequently suffer any side effects. Nevertheless, this event is still reportable since, in a worst-case scenario, the patient could have gone into shock (it could have led to a serious deterioration in health)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
Swissmedic - see in particular
- Users and operators
- Vigilance-System (reporting of incidents)
MDR- see in particular article
- Art. 87 for timelines to report serious incidents
FEDLEX – laws are available online under numbers
- 812.213 MedDO
- 812.21 TPA
MedDO – see in particular articles
- Art. 66 reporting obligations
- Art. 67 for MV reporting system in hospitals
TPA – see in particular articles
- Art. 58 market surveillance
- Art. 59 mandatory notification, notification system and the right to notify