AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
2.6 Databases Containing Personal or Sensitive Data The processing of personal data (including sen- sitive data) within databases is subject to com- pliance with the GDPR, (potentially) the FOG and the Austrian Data Protection Act ( Datens- chutzgesetz , or DSG). 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices The distinction between medicinal products and medical devices is made in accordance with the product definitions as outlined in the AMG (Sec- tion 1, paragraph 1) and the MDR (Article 2(1)). “Medicinal products”, within the meaning of the AMG, are substances or preparations of sub- stances that either: • are intended for use in or on the body and as agents with properties to cure or alleviate or prevent diseases or pathological complaints (so-called presentation medicinal products); or • may be applied in or on the body or adminis- tered to a human (so-called functional medici- nal products) with a view to either: (a) restoring, correcting or modifying physi- ological functions by a pharmacological, immunological or metabolic action; or (b) making a medical diagnosis. According to the MDR, the term “medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human
beings for one or more of the following specific medical purposes, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means: • the diagnosis, prevention, monitoring, predic- tion, prognosis, treatment or alleviation of disease; • the diagnosis, monitoring, treatment, alle- viation of, or compensation for, an injury or disability; • the investigation, replacement or modifica- tion of the anatomy or of a physiological or pathological process or state; and • for providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tis- sue donations. Furthermore, devices for the control or support of conception and certain products specifi- cally intended for the cleaning, disinfection or sterilisation of devices will be deemed medical devices. The distinction between medicinal products and medical devices can be made, in most cases, on the basis of the principal mode of action of the product (see Article 1, paragraph 6(b) of the MDR). A product with an essentially pharma- cological, immunological or metabolic action should not be classified as a medical device. The principal mode of action of medical devices is mostly of a physical or mechanical kind. In the case of diagnostic devices, distinction must be made on the basis of the nature of the product (substance/instrument, apparatus, etc) and the place of application (in vivo or in vitro).
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