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The regulatory framework for medical device manufacturers has changed greatly in recent years. In particular, the European Commission Recommendation 2013/473/EU interprets and clarifies the requirements of the European medical device directives. Some of these requirements also change the performance of conformity assessment procedures carried out by the Notified Bodies in these areas. Among other things, the implementation of regular unannounced audits is planned. In order to enable the planning, the Recommendation 2013/437/EU proposes that manufacturers report periods when medical devices falling under the notified bodies' certificates will not be manufactured to the Notified Body.
With this website we would like to provide a simple platform which enables you to send the relevant information to us. Please note that for a safe planning of unannounced audits, your message must be sent at least 3 months prior to the planned production time.