The registration and implementation of a smartphone application. As a Medical Device in the Austrian health system

      Аннотация: Medical smartphone applications that meet the definition of a medical device are required to comply with safety and performance standards of the Medical Devices Directive 93/42/EEC. In Austria, the highlight of the process of registration and implementation of a medical smartphone application is obtaining the CE mark, which ensures the compliance with the European Union safety and performance standards. The conformity assessment route for obtaining CE mark leans on the classification of the smartphone application as a medical device and the risk associated with the use by patients. A medical device associated with a low risk for the user stands for a straightforward and accessible conformity route. The process of registration and implementation of a smartphone application in the Austrian health system is a widespread and complex process. Therefore, a set of step by step guidelines through official regulations and were created based on European Union regulations, guidelines from other countries health ministries and information collected through the internship period at BHM e-health Services.

Ключевые слова: Medical Smartphone application, Medical Device, Regulations, Standards, CE mark, Registration, implementation.