Clinical trials with medical devices

New date: Electronic submission form per 24.03.2016!

As per March 24th, 2016, the new electronic submission form for initial applications of clinical investigations and performance evaluations will come into effect as an requirement for a valid submission.

 

The list of fields is based on the mandatory content for the EUDAMED database and addtional information. The electronic form will reduce the administrative burden for applicants and agency and replace all former paper forms.

 

A completed application form in the new format needs to be submitted with the next submission for all ongoing studies submitted with the now outdated application forms.

 

Access to the notification form: https://applicationform.basg.gv.at/mpgform/

Aspects to consider for submission to the Competent Authority

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).

Contact

Institute Surveillance | Clinical Trials | clinicaltrialsagesat

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Created: 08.03.2009 | Page last modified: 26.01.2015

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