Medical devices may only be placed on the Union market if the requirements of the respective European regulation (MDR, IVDR) are met. These include, among other things, compliance with the general safety and performance requirements, the selection and implementation of an appropriate conformity assessment procedure, and the issuance of a corresponding declaration of conformity. By affixing the CE marking, the manufacturer declares that the respective medical device meets all applicable requirements.

The manufacturer is solely responsible for the medical device and its design and properties. He defines the medical intended purpose, in particular the type and manner of the principal effect and application of the medical device, and classifies it in the respective medical device class. For medical devices of higher risk classes, a notified body must be involved.

The amended Regulation of the Austrian Federal Office for Safety in Health Care (BASG) on the electronic transmission of applications and notifications (Electronic Submission Regulation 2011 – EEVO 2011) entered into force on 29 February 2024.

This guidance document is intended for applicants of medical devices in accordance with Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), medical devices within the meaning of Section 1(2) of the Austrian Medical Devices Act 2021 (Medizinproduktegesetz 2021, MPG 2021), Federal Law Gazette I No. 122/2021, as amended, as well as non-medical products.

For additional information regarding the application procedure, please refer to the BASG website.

The guidance document is available at the following link: Guidance Document.