After placing a medical device on the market, a manufacturer is required to track and if necessary to improve it. The manufacturer must take action if a risk exists for the user. The manufacturer must inform users and the Inspectorate of such action by a Field Safety Notice. This might include a recall, amended instructions for use or extra information about the medical device.
Field Safety Notices about medical devices that have been reported to the Inspectorate on the Dutch market are shown below. We began publishing these notices online on 15 December 2015. You can find the published notices here.