AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
the MDR and IVDR categorise devices based on their purpose or use, such as active devices, implantable devices, invasive devices, or single- use devices. They also classify devices accord- ing to their inherent risks: • medical devices are classified into Classes I, IIa, IIb, and III; while • IVD devices are categorised into Classes A, B, C, and D. As of 1 February 2022, the regulatory system for clinical trials of medicinal products underwent a comprehensive restructuring aimed at further harmonising the rules on the conduct of clini- cal trials within the EU member states. The legal framework of clinical trials on medicinal products is now essentially defined by the CTR, thereby replacing the former system for clinical trials based on Directive 2001/20/EC. Supplemen- tary provisions for national implementation and within the scope of so-called opening clauses of the CTR have been introduced into the Austrian legal system through the AMG. 2. Clinical Trials 2.1 Regulation of Clinical Trials If genetically modified organisms (GMOs) are used for therapeutic purposes – as defined in Section 4(24) of the Austrian Gene Technology Act ( Gentechnikgesetz , or GTG) – in the course of a clinical trial, a prior permit according to Sec- tion 74 of the GTG must also be obtained. Clinical trials of medical devices (known as “clin- ical investigations”) are mainly regulated by the MDR and clinical trials of IVD devices (known as “performance studies”) are regulated by the IVDR. Supplementary provisions have been included in the MPG.
For non-interventional studies, the CTR and the MDR/IVDR provisions do not apply. Instead, there are specific national provisions in the AMG and the MPG for these studies, including provi- sions concerning data protection and inspec- tions by the BASG. The following may also apply: • general provisions of civil, criminal and data protection law; or • specific rules for clinical research under, for example, the Austrian Hospital and Sanatoria Act ( Krankenanstalten- und Kuranstaltenge- setz , or KAKuG) or the Austrian University Act 2002 ( Universitätsgesetz , or UG). 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Since 31 January 2023, all new applications for clinical trials of medicinal products must be submitted in accordance with the CTR. The authorisation procedure is initiated by the spon- sor sending the application dossier to the EU member states concerned via the EU portal, known as the Clinical Trials Information System (CTIS). The reporting member state must then carry out a validation within ten days and notify the sponsor via the portal of the results. In Aus- tria, the BASG is responsible for the validation procedure, whereby the ethics committee can issue an opinion on certain parts of the applica- tion (Section 31, paragraph 4 of the AMG). The validation procedure is followed by the evalua- tion procedure, which is divided into two parts. • Part I is a co-ordinated assessment of the application between the reporting and con- cerned member states takes place, in which aspects of the clinical trial – such as whether it is minimally interventional, the expected therapeutic and public health benefits, and the risk of harm posed to the trial subjects – are evaluated. The assessment report must
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