Field safety corrective actions (FSCA) Report Form (Initial, Final and Follow-up) according to § 3 (1) of the Ordinance on Medical Devices Vigilance by the Manufacturer, Authorised Representative or Importer (or Distributor)

For a differentiation or classification decision by BfArM an informal application for classification and/or differentiation according to § 13 paragraph 2 or paragraph 3 MPG must be submitted to BfArM.

The BfArM may allow in exceptional circumstances market access of medical devices, which have not undergone a regular conformity assessment procedure for CE marking, in Germany for a limited period of time, if this is in the interest of health protection. This may be the case, if there is no alternative, i.e. if the urgent medical need cannot be met otherwise, and from the point of view of health protection, the completion of a regular conformity assessment procedure for the medical device cannot be waited for.