PDF 3409KB - DAR - Bundesanstalt für Materialforschung und ...

Summary of national notification system: SWEDEN
1. written reports?
• Content The notified body must keep SWEDAC informed about its work as a notified body and in particular report any changes
that might affect its position and appointment as a notified body.
• Frequency There is no stipulated frequency for reports. The NBs are requested to inform SWEDAC about changes and other questions concerning
their activities at the surveillance.
2. Reporting of information to
competent authorities on incorrect use of CE
mark and/or certificates issued by NB
Monitoring of subcontracted activities and
activities of foreign subsidiaries
No general regulations or demands exist but specific legislation corresponding to some of the new approach directives (e g medical
devices directive) are implemented (see also lin between authorities and notified bodies).
The notified body must report to SWEDAC any use of subcontractors and for what tasks the notified body intends to use the
subcontractor. The notified body takes full responsibility for the competence of its subcontractor, who must meet the same requirements
concerning technical competence as the notified body itself. The notified body must keep a register of its subcontractors. The register
must contain detailed information on the competence of the subcontractors and their ability to meet the relevant requirements.
5