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Vigilance Reports


The Initial and Final Report Forms are the official report forms in Germany.  They follow the agreement of the European member states, but have some local specifics.  As these forms are provided in both German and English, we use them also for the notification of Competent Authorities in other member states in regards to incidents and near incidents, and so far they have been accepted.

You may download the forms, fill them out directly on your screen and forward them via e-mail attachment to MDSS.  Should you not have all the information which is requested available, please forward the form with as much data as possible.  We will respond immediately and inquire about the missing information.  Normally, we are able to resolve and guide our clients on these aspects. 

In case of an advisory notice issued by a manufacturer, the Competent Authority would also like to be informed.  In this case, all applicable Competent Authorities need to be notified, plus the Competent Authority where the CE mark was issued and, in case of risk class I, also the Competent Authority where the Authorized Representative is located. 

 

 

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