EC receives 26 vigilance reports in two months:
This article was originally published in Clinica
A total of 26 medical device vigilance reports were sent by the regulatory authorities in the European Economic Area and by the Swiss medical device authority to the European Commission between January 29 and March 26 2003. According to the Commission, the majority of these reports came from Germany, a total of 11 in all, while the UK was the next most active reporter, having sent six reports. The remaining reports came from Belgium (1), France (3), the Netherlands (1), Norway (1), and Switzerland (1). Vigilance reports are those adverse incident reports that have been received by the competent authorities from medical device manufacturers and users and which are deemed serious enough to need to be communicated to all authorities in Europe so that joint action can be taken to tackle the health threat represented by the device.