The Austrian Medical Devices Registry is a web-based, free of charge database that comprises data of responsible natural or legal persons bringing medical devices, incl. in vitro diagnostics and custom-made devices, onto the Austrian market (for the first time in the European Economic Area). It also includes notified bodies and testing laboratories, inspection- and certification bodies. Registration is only possible through the internet website medizinprodukteregister.at and is not publicly accessible.
Users only have access to their registered data, but cannot view data from other companies. Data to be entered in the Austrian Medical Devices Registry is explicitly mentioned in national law. Registrations have to be kept up-to-date by the user.
Registration is obligatory for all persons and companies (manufacturers, importers, authorised representatives, sterilising companies, system(s) manufacturers) based in Austria AND
- those responsible for placing on the market medical devices (including in-vitro diagnostics and custom-made medical devices) for the first time in the European Economic Area (and Switzerland)
- as well as for certifiers, testing laboratories and inspection bodies of medical devices based in Austria.
The registration of distributors based in Austria is voluntary but strongly recommended.
More information can be found in the FAQ list.