Clinical Investigations and Performance Evaluations

Electronic notification form for clinical investigations and performance evaluations

The application form can be accessed, completed and uploaded for changes under the following link:

Deutsche Übersetzung der Feldbezeichnungen

Notification of Serious Adverse Events

  • sae reporting form en.xlsx27 KNotification form for Serious Adverse Events in a clinical investigation of a medical device or performance evaluation of an in-vitro diagnostic (Global) [Updated: 17.12.2015]
  • F I209 ENG SAE Klinische Pruefung MP Leistungsbewertungsprüfung.docx0.96 MTo be used additionally for notification of a Serious Adverse Event in a clinical investigation/performance evaluation ongoing in Austria. This form is not to be used for notifications according to §70 MPG. For this the reporting requirements for Vigilance and Market Surveillance must be followed. [Updated: 01.02.2017]

Notification of Amendments

  • F I200 Amendment Form MPG.docx195 KBilingual amendment form for amendments to clinical investigations and performance evaluations; [Updated: 08.04.2016]

Notification of the end of a clinical investigation/performance evaluation

Created: 06.04.2009 | Page last modified: 05.08.2016

© Austrian Federal Office for Safety in Health Care
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