Swissmedic: Reporting Serious Events for Medical Devices & IVDs

Swissmedic recently unveiled an insightful video that underscores the critical nature of reporting serious events. Aimed at manufacturers and device users with limited reporting experience, the video serves as a valuable educational tool, shedding light on the procedural aspects and the legal imperatives of incident reporting. 

The video also effectively communicates why Swissmedic reaches out to manufacturers upon receiving a user report and provides clarity on Swissmedic’s protocol for contacting manufacturers as an initial step in the reporting process (particularly when a Manufacturer Incident Report (MIR) has not been filed, or the manufacturer is unaware of the need to report an incident). 

This proactive approach by Swissmedic has become increasingly common, with the regulatory body frequently requesting detailed information from medical device and IVD manufacturers regarding incidents reported by users or hospitals. It is a statutory requirement, as per the Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Devices Ordinance (IvDO), for professional users who encounter a serious incident to notify both the supplier and Swissmedic. 

The determination of whether an incident is serious and warrants notification to Swissmedic rests with the user. Such incidents must be reported to Swissmedic using the appropriate forms available on the Swissmedic website. Moreover, it is a legal obligation for hospitals to establish a reporting system and appoint a designated individual responsible for the reporting of serious incidents. Swissmedic also reserves the right to inspect hospital reporting systems to ensure compliance. 

For more information and to access the reporting forms, please visit Swissmedic’s website reporting section here. 

______________________________________________

Please reach out to us if you need help in reporting a serious event for your medical device or IVD or if you have any questions in regards to Swissmedic’s educational video. 

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative
  • Swiss Regulatory Importer
  • Regulatory Consulting