Austria

Ministry of Health

Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK)

Regulatory Authority

Federal Office for Safety in Health Care (BASG)
Operated on behalf of BASG by the Austrian Medicines and Medical Devices Agency (AGES MEA)

Medical Device Regulation

Medical Devices Act 2021 (MPG 2021) and relevant ordinances

Official Language

German

Classification

Medical Device – Class I, IIa, IIb, III
IVD – Class A, B, C, and D (under IVDR)

Registration Process

1. Determine the classification of the medical device under MDR or IVDR.

2. If the manufacturer is outside the EEA, appoint an Authorized Representative within the EEA or Switzerland.

3. Prepare the CE-marked Technical Documentation in accordance with MDR/IVDR.

4. Ensure the Authorized Representative is registered with the Austrian Medical Device Registry if they are based in Austria.

5. Include the name and address of the Authorized Representative on labelling.

6. Devices must comply with CE marking requirements before market placement.

7. Notify BASG if required (e.g. for custom-made devices or market surveillance purposes).