Forms
| Title | Date | Download |
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Incident and 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) PDF-Form (use of Adobe Acrobat 9.X recommended) |
2012.01.10 |  download (file size: 548 KB) |
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Report form for reporting of serious adverse events (SAE) in clinical trials or performance evaluations for use by sponsors and investigators according to § 3 (5) of the Ordinance on Medical Devices Vigilance PDF-Form (use of Adobe Acrobat 9.X recommended) |
2012.01.09 | download (file size: 741 KB) |
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XSD's for manufacturers, who wish to report directly from their database into an XML file that fulfils the requirements for electronic reporting.
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2010.02.08 |  download (file size: 11 KB) |
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Form of the registration of manufacturers and devices, In Vitro Diagnostic Medical Devices Directive, Article 10 DOC-Form |
2000.06.06 |  download (file size: 210 KB) |
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Form of the registration of manufacturers and devices, In Vitro Diagnostic Medical Devices Directive, Article 10 PDF-Form |
2000.06.06 | download (file size: 42 KB) |
Advice for notifications of the first placing on the market
Information concerning notifications of the first placing on the market of medical devices (except in vitro diagnostic medical devices) is available on the following DIMDI website.
Advice for notification of Clinical Investigations / Performance Evaluations
Notification of Clinical Investigations / Performance Evaluations
Notes for realising consultation procedures and submission of documentations in connection with ancillary medicinal substances used in medical devices
| Title | Date | Download |
|---|---|---|
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Application for a consultation on an ancillary medicinal substance used in a device (Antrag auf Konsultation für ein Medizinprodukt mit einem die Wirkung des Produkts ergänzenden Arzneimittelanteil) |
2005.06.17 |  download (file size: 428 KB) |