Clinical Trials
Clinical Trials with Medical Devices
Guideline on notification of clinical investigation of a medical device / performance evaluation
L_I99_ENG_Leitfaden_klinische_Pruefung_MP_IVD.doc (187.5 KB) Notification of a clinical investigation with a medical device or a performance evaluation with an in vitro diagnostic.
L_I102_ENG_Überblick_über_Meldeverfahren.doc (120.5 KB) Overview of notification procedures in accordance with § 40 of the Austrian Medical Devices Act.
L_I103_ENG_Überprüfung_der_Anwendbarkeit_von___40_5.doc (118.5 KB) Clinical investigations/performance evaluations in accordance with § 40 (5) of the Austrian Medical Devices Act
Clinical investigation of a medical device
F_I203_ENG_Meldung_Studie_MP.docx (1.04 MB) Notification of a Clinical Investigation with a medical device. Last modified: 17.05.2012.
F_I205_ENG_Beiblatt_Pruefzentren_MP.docx (969.56 KB) Supplementary form for Clinical Investigations—Investigational Sites, Notification of a Clinical Investigation with a medical device. Last modified: 17.05.2012.
L_I100_ENG_Unterlagen_klinische_Pruefung_MP.doc (123 KB) Documents to be submitted as part of an adequate and complete notification of a Clinical Investigation with a medical device (including active implantable medical devices)
Performance evaluations of in-vitro medical devices
F_I324_ENG_Meldung_Leistungsbewertungsprüfung.doc (1.17 MB) Notification of a Performance Evaluation of an In Vitro Diagnostic medical device
F_I326_ENG_Beiblatt_Leistungsbewertungspruefung.doc (1010 KB) Supplementary form for Performance Evaluations—Sampling/Evaluation Sites, Notification of a Performance Evaluation with an In Vitro Diagnostic medical device
SAE Reporting
F_I209_ENG_SAE_Klinische_Pruefung_MP_Leistungsbewertungsprüfung.doc (1.02 MB) Notification of a Serious Adverse Event occurring during a Clinical Investigation with a medical device or a Performance Evaluation with an In Vitro Diagnostic medical device
Amendments
F_I200_ENG_Meldung__Amendment_klinische_Prüfung_MP_Leistungsbewertungsprüfung.docx (214.07 KB) Notification of an Amendment to a clinical investigation plan with a medical device or performance evaluation with an in vitro diagnostic medical device.
End of trial notification
F_I207_ENG_Beendigung_Studie_MP_Leistungsbewertungspruefung.doc (1 MB) Notification of the end of a Clinical Investigation with a medical device or a Performance Evaluation with an In Vitro Diagnostic medical device
INFOBOX
Created: 01.09.2009 | Page last modified: 19.03.2012