| Regulatory Authority | Austrian Federal Office for Safety in Health Care |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | Medical Device: I, IIa, IIb and III IVD: A, B, C, D |
| Medical Device Regulations | Medical Device Act 2021 | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines |
Classification is to be carried out in accordance with Annex VIII to the MDR | Click Here |
| Registration Process | Registration requirement | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Conformity Assessment Route |
Refer to Article 52 – Conformity assessment procedures | Click Here |
| Technical Documentation Format |
The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements. | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in German Language |
| Database | Medical Device Register | Click Here |
| Certificate of Free Sale |
A Free Sale Certificate (FSC) may be required for the export of CE-marked medical devices and in vitro diagnostics outside the Union. | Click Here |
| Reportable Incidents |
Professionals who use or operate medical devices, as well as technical safety officers of hospitals, must immediately report to the Federal Office for Safety in Health Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The manufacturer or, if applicable, the authorized representative of the product must also be informed. In the case of hospitals, this must be done uniformly by way of the medical director, except in the case of other imminent danger. A serious incident is defined as an incident that directly or indirectly led, might have led or might lead to any of the following:
If there is a suspicion of counterfeiting of a medical device, this must be reported immediately to the BASG. | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | Registration is obligatory for all persons and companies (manufacturers, importers, authorised representatives, sterilising companies, system(s) manufacturers) based in Austria. 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. |