The regulatory framework for manufacturers of medical devices has changed considerably in recent years. In particular, the Recommendation of the European Commission 2013/473/EU interprets and specifies the requirements of the European Medical Device Directives. Some of these specifications also change the implementation of the conformity assessment procedures of the Notified Bodies in these areas. Among other things, the implementation of regular unannounced audits is planned. In order to facilitate planning, Recommendation 2013/473/EU stipulates that manufacturers must notify the Notified Body of periods during which medical devices are not manufactured.
With this page we would like to provide you with a simple platform to send us the relevant data. Please note that for a reliable planning of unannounced audits, your reports must be submitted at least 3 months before the planned non-production times.