If you have not already made a plan for the transition, it is high time that you do so as 31 July 2006 is the absolute deadline where manufacturers of medical devices must have completed their transition to the new standard. This requirement applies to companies registered for ISO 13485:1996 and those holding certificates in accordance with one of the quality system annexes of Directive 93/42/EEC concerning medical devices and Directive 98/79/EC concerning in vitro diagnostic medical devices.

For manufacturers selling class II, III and IV devices (Canadian regulation) in Canada the transition date is even before. In this case the transition must be completed no later than 15 March 2006.

In either case it is important that you inform DGM about your transition plans and provide us with the revised quality system documentation in good time making it possible for us to audit your quality system 2-3 months before the expiry date.

For further information about transition to ISO 13485:2003, please contact DGM at +45 39 96 64 00.

Related staff Bent Buus