The procedure for processing user reports has been updated on the basis of Swissmedic's duty to compile and evaluate reports (Article 15e of the Medical Devices Ordinance (MedDO, SR 812.213)) and its obligation to maintain secrecy and data confidentiality (Articles 61 and 62 of the Therapeutic Products Act (TPA, SR 812.21)). Under the new procedure, specialists or contact persons at hospitals who submitted a serious incident report will only receive a confirmation of receipt from Swissmedic containing the Swissmedic reference number. However, no information will be sent when the manufacturer has completed its investigations. Swissmedic will continue to use the information you submit even after the manufacturer has completed its investigations.
More information on the procedure for processing serious incident reports can be found in the updated information sheet:
The report form for serious incidents has also been updated to reflect feedback from manufacturers and contact persons at various hospitals. You can find the new version (in German) at:
The changes take effect on 1 May 2016.