Clinical Trials
Submitting a notification to the Competent Authority
As of May 2011, all clinical investigations with medical devices have to be entered into the European Database of Medical Devices EUDAMED by a national authority within the European Economic Area (EEA); in Austria, the authority responsible for doing so is the Austrian Federal Office for Safety in Health Care, BASG. The clinical investigation must be entered into the database by the national authority that is first notified of the clinical investigation.
Before commencing a clinical investigation of a medical device or a performance evaluation of an in vitro diagnostic medical device, the Austrian Federal Office for Safety in Health Care (BASG) has to be notified according to Article 40 of the Medical Devices Act.
The procedure for notification as well as any obligations and processes to be followed by the sponsor are set out in the “Guideline on the notification of a clinical investigation of a medical device or the performance evaluation of an in vitro diagnostic medical device”(L_I99_ENG).
Information on the documents to be submitted or to be made available on request is summarized in the “documents for clinical investigation” (L_I100_ENG) and “documents for performance evaluations” (L_I101_ENG) lists.
Notification procedure
After formal assessment of the documents submitted by the applicant, the BASG will confirm that the notification is complete and valid. The clinical investigation can be started under the following conditions:
- Clinical investigations of high-risk products (AIMDs, class III medical devices, implantable and long-term invasive medical devices falling within class IIa or IIb) can start after a waiting period of 60 days from the day of formal completeness of the notification which needs to be confirmed by the BASG.
- Clinical investigations of low-risk medical devices and performance evaluations of in vitro diagnostic medical devices can start once the receipt of a complete and valid notification has been confirmed by the BASG.
- Any changes to the protocol made while the clinical investigation is ongoing have to be notified to the BASG in accordance with Article 40a of the Medical Devices Act.
- Also, according to Article 42 (8) of the Medical Devices Act, the sponsor must immediately report to the BASG any serious adverse event occurring during the clinical investigation.
- Finally, BASG must be notified of the end of a clinical investigation or performance evaluation.
INFOBOX
For further information please contact
Inspections, Medical Devices & Haemovigilance | inspektionenagesat | +43 (0) 50 555-36402
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Created: 06.04.2009 | Page last modified: 17.05.2011