Accidents and the Vigilancesystem

Monitoring incidents and near-accidents with medical devices is an important task for the Swedish Medical Products Agency.

Users have an obligation to report all serious accidents according to the regulations, SOSFS 2008:1. Users report to the distributor and to the Swedish Medical Products Agency.

Correspondingly, manufacturers are obliged to report serious incidents with devices CE-marked according to LVFS 2001:5, LVFS 2003:11, LVFS 2001:7 (AIMDD, MDD, IVD) and which have occurred in Sweden. Primarily the manufacturer, eventually through the distributor, informs the users of measures to be taken, recalls (Field Safety Corrective Actions), or risks associated with the medical device. Requirements on the so called vigilance reporting system are to be found in the Guide MEDDEV 2.12/1 (PDF) from the EU-Commission.

The form for the manufacturer's incident report (initial, final or follow-up) as well as the form for the Field Safety Corrective Action report are specified in MEDDEV 2.12/1 and fill-in Word versions are provided to the right. The vigilance reports could preferably be sent to 


Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | | Contact information