What is the Austrian Medical Devices Registry?
The Austrian Medical Devices Registry is a free, web-based database that contains data on manufacturers of custom-made devices, distributors of medical devices, as well as testing, inspection, and certification bodies. Registration in the database can only be carried out via the website medizinprodukteregister.at . Users can only view the data they have entered themselves; data from other companies are not accessible. The data to be entered are explicitly listed in the Medical Devices Reporting Ordinance. Registrants are required to keep their submissions up to date.
Who has to register with the Austrian Medical Devices Registry?
The Austrian Medical Devices Act 2021 (MPG) entered into force in July 2021.
It establishes a registration obligation for:
- manufacturers of custom-made devices based in Austria;
- distributors of medical devices based in Austria; and
- testing, inspection, and certification bodies (TIC bodies) based in Austria.
In addition, the Medical Devices Reporting Ordinance 2024, which entered into force on 1 May 2024, explicitly specifies the data fields to be completed.
Due to the mandatory use of the first EUDAMED modules, national registration requirements will no longer apply to manufacturers, system and procedure pack producers, authorised representatives, and importers. These actors will no longer be required to register in the Austrian Register of Medical Devices, as these obligations are fully covered at EU level through EUDAMED.
What is the legal basis for registration?
The Austrian National Public Health Institute (Gesundheit Österreich GmbH) was commissioned by the Austrian Federal Ministry for Social Affairs, Health, Care and Consumer Protection to set up and maintain the Austrian register for medical devices as well as the register for testing, inspection and certification bodies. This is set out in the Medical Devices Act 2021 (BGBl. I No. 122/2021).
The Medical Device Reporting Ordinance 2024 (BGBl. II No. 23/2024) explains the registration requirements for distributors, manufacturers of custom-made medical devices and testing, inspection and certification bodies in more detail and explicitly lists the tasks of the Austrian National Public Health Institute in this context.
Are there any fees associated with the registration with the Austrian Medical Devices Registry?
The Austrian Medical Devices Registry is a cost-free online database.
However, regardless of registration, according to the “Medical Devices Fee Ordinance” every person or company delivering medical devices to end users in Austria, is obliged to pay an annual fee to the Federal Office for Safety in Healthcare (Bundes Amt für Sicherheit im Gesundheitswesen). More information can be found there: http://www.basg.gv.at/medizinprodukte/medizinprodukteabgabe/
Who has access to the Austrian Medical Devices Registry? Can I as a manufacturer access the information stored in the Austrian Medical Devices Registry?
Only registered users can access the information they have provided.
In addition, the Federal Ministry of Social Affairs, Health, Care and Consumer Protection, the Federal Office for Safety in Healthcare (Medical Market Supervisory Authority) and the Austrian National Public Health Institute (Gesundheit Österreich GmbH) have access.
Data within the medical device registry is not public. As of May 1, 2024, register data (except personal data) of distributors, manufacturers of custom‐made medical devices and testing, inspection and certification bodies is publicly accessible. Further information can be found in the Medical Device Reporting Ordinance 2024.
Where can I find partners in Austria for distribution?
Information about medical devices distributors can be found, for example, on the webpage of the Austrian Economic Chamber (https://firmen.wko.at/Web/SearchSimple.aspx, only available in German), or directly at the
Austrian Economic Chamber
Straße der Wiener Wirtschaft 1
1020 Vienna
Phone: +43 1 514 50 3216
E-Mail: foto-medizinproduktehandel@wkw.at
Website: https://www.wko.at
Austromed (the special interest group of medical devices manufacturers and distributors)
Seidengasse 9/1.4
1070 Vienna
Phone: +43 1 877 70 12
E-Mail: office@austromed.org
Website: http://www.austromed.org/
LISA - Life Science Austria
Organised through the regional life science clusters, LISA represents companies in the therapeutic, medical technology and diagnostic sectors as well as providers of enabling technologies and related service companies. LISA is run by Austria Wirtschaftsservice GesmbH (aws) on behalf of the Federal Ministry of Labour and Economy (BMAW).
Rechte Wienzeile 225
1120 Wien
Website: https://www.lifescienceaustria.at/
Austrian Life Sciences Directory
Organised through the regional life science clusters, LISA represents companies in the therapeutic, medical technology and diagnostic sectors as well as providers of enabling technologies and related service companies. LISA is run by Austria Wirtschaftsservice GesmbH (aws) on behalf of the Federal Ministry of Labour and Economy (BMAW).
Rechte Wienzeile 225
1120 Wien
Website: https://www.lifescienceaustria.at/
How does pricing / procurement of medical devices work in Austria?
Prices of medical devices are not regulated in Austria and are subject to negotiations / public procurement processes between manufacturers and purchasers (social insurance institutions, hospitals, etc.).
Are medical devices reimbursed in Austria in the out-patient sector / in the in-patient sector and how does it work?
No uniform reimbursement list of medical devices exists in Austria:
Outpatient sector:
The individual social insurance institutions negotiate contracts and tariffs with medical device manufacturers and distributors, as there is no standardised application process. Generally, medical devices are reimbursed if listed in a reimbursement catalogue by each social insurance institution and prescribed by a medical practitioner. Depending on the patient's social insurance, patients may receive the medical device without any cost or with only a partial co-payment. Alternatively, patients might need to pay for the device upfront and then be reimbursed by the social insurance.
Inpatient sector:
In the inpatient sector, reimbursement is managed through lump sums which can be generated for reimbursement of the procedure and diagnosis-orientated case groups in hospitals (“Leistungsorientierte Krankenanstaltenfinanzierung – LKF”). Some, mainly highly innovative, medical devices are individually reimbursed through the individual medical services catalogue (Medizinische Einzelleistungen, MEL). Applications for new reimbursement groups can be filed by hospitals each year in autumn. The decision is taken by the Federal Healthcare Commission (Bundesgesundheitskommission) based on recommendations by experts (incl. HTA).
The decision which medical device is finally purchased is taken by the individual hospitals or centralised bodies at the level of hospital associations.
Where can I find information regarding notified bodies and certificates in Austria?
All notified bodies in Europe can be found on the Single Market Compliance Space (SMCS) website: EUROPA – European Commission – Growth – Regulatory policy - SMCS
The only notified body in Austria is QMD Services GmbH.
What/who is an Authorised Representative (AR) and what rights and obligations does he/she have?
A manufacturer located outside the Common Market (EEC, Switzerland) placing medical devices in the Common Market, shall explicitly designate a single Authorised Representative within the area of the Common Market. The Authorised Representative has to be printed on the labelling and the instructions for use. More information can be found here.
What do I have to do in case of a medical device adverse incident in Austria?
Adverse incidents with medical devices (including in-vitro diagnostics) have to be reported to the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen). Further information and all relevant forms can be found there: https://www.basg.gv.at/en/market-surveillance/reporting/medical-devices-vigilance#c22082
Where can I find information regarding clinical trials of medical devices in Austria?
Before commencing a clinical investigation of a medical device or a performance evaluation of an in vitro diagnostic medical device, the Austrian Federal Office for Safety in Health Care (BASG) must be notified. More information can be found there: https://www.basg.gv.at/en/healthcare-professionals/clinical-trials/clinical-trials-of-medicinal-products-reg
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
What is EUDAMED?
EUDAMED is the European Database on Medical Devices. With the Medical Devices Regulations (MDR and IVDR), EUDAMED has been introduced to ensure traceability of the devices within the supply chain and strengthen market surveillance and transparency in the European Union.
From 28 May 2026 on, economic operators are obliged to register in EUDAMED and to enter their data accordingly.
The EUDAMED website has been accessible since 1 December 2020 at the following link:
https://ec.europa.eu/tools/eudamed/#/screen/home
This website allows users to search for economic operators, competent authorities, and certificates.