AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
be prepared and submitted within 45 days of validation; however, this term may be extend- ed under certain conditions. The responsi- bilities regarding Part I of the assessment procedure are divided nationally between the BASG and an assessing ethics committee (Section 35 of the AMG). • Part II of the evaluation procedure includes the aspects to be assessed nationally by each member state – for example, require- ments for informed consent, patient recruit- ment, and subject insurance. The evaluation report must also be submitted within 45 days of validation. In Austria, the responsibility for preparing the assessment report in Part II is assigned to the evaluating ethics committee. The decision to authorise the clinical trial must then be taken by each member state within five days of the conclusion of the evaluation proce- dure. If a timely notification is not made, the con- clusion regarding Part I of the assessment report is automatically deemed to be the decision of the respective member state. The approval of a clinical investigation into a medical device for the purposes of the conform- ity assessment referred to in Article 62, para- graph 1 of the MDR essentially follows the MDR. Depending on the type of investigation, different procedures are provided for (eg, authorisation procedure/notification procedure/instruction procedure). An application for authorisation must be submit- ted electronically to the BASG. Upon receipt of the application, the BASG must carry out the validation within ten days. With regard to Class I investigational devices or Class IIa/IIb non-invasive devices, the clinical investigation may be commenced immediately
after validation – provided that the BASG has confirmed proper notification and the ethics committee has given a favourable opinion (ie, notification procedure). In the case of other investigational devices (Class III investigational devices or Class IIa/IIb invasive devices), the clinical investigation may only commence after notification of the authori- sation by the BASG – again with the prerequisite that a favourable opinion by the competent eth- ics committee must be provided. The decision about the authorisation must usually be commu- nicated to the sponsor within 45 days of valida- tion (ie, authorisation procedure). For clinical investigations of medical devices that already bear a CE marking, thereby confirming conformité européenne (“European conformity”), a different procedure applies under certain con- ditions (Article 74 MDR). The sponsor must notify the BASG of the conduct of such investigation at least 30 days before it begins. In this case, the BASG will confirm the notification without further subsequent assessment (ie, information procedure). Clinical investigations of medical devices for other purposes than the demonstration of con- formity are also subject to prior approval by the BASG if they have an impact on the diagnostics and/or therapy of a trial subject (Article 82 of the MDR, in conjunction with Section 13, paragraph 3 of the MPG); otherwise, it is only necessary to conduct an information procedure. For performance studies on IVD devices, the provisions of the MPG are largely applicable mutatis mutandis – although there are certain exceptions (see Article 66 et seq of the IVDR and Section 36 of the MPG for comparison).
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