What is the Austrian Medical Devices Registry?
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 website www.medizinprodukteregister.at. The data is not publicly accessible, except for distributors and manufacturers of custom-made devices. 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 (cf. Question No. 3). Registrations have to be correct and kept up-to-date by the user.
Who has to register with the Austrian Medical Devices Registry?
Until EUDAMED is fully available (for further information on EUDAMED, see Question No. 16), registration is obligatory for:
- all persons and companies (i.e. manufacturers, importers, authorised representatives, sterilising or assembling companies and system(s) manufacturers),
- responsible for placing medical devices (including in-vitro diagnostics and custom-made medical devices) on the market for the first time in the European Economic Area,
- based in Austria.
Since July 2021, registration is also obligatory for Austrian based:
- Distributors of medical devices,
- Manufacturers of custom‐made medical devices,
- Testing, inspection and certification bodies
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.
As a manufacturer located outside of Austria, do I have to register with the Austrian Medical Devices Registry?
If your product is already on the market in a country within the EEA (and Türkiye) and correctly registered in the country where it was placed on the market for the first time, you do not need to register the product in Austria.
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 (cf. Question No. 2) 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. Furthermore, the national competent authority(s) or bodies entrusted with enforcement as well as employees of responsible bodies of the European Commission can have access to the registry.
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.
My products are already registered in another country of the European Union. Do I have to register my products again within the Austrian Medical Devices Registry?
In case a CE-marked product has already been placed somewhere on the EEA market (or Türkiye) and is already registered in the national registry of the corresponding country, it is not necessary to register the product again in the Austrian Medical Devices Registry. (cf. Question No. 2)
I am a manufacturer of medical devices (incl. custom-made medical devices) or IVDs outside of Austria and I want to sell my products on the Austrian market, what do I have to do?
Please check if you fulfil the following requirements:
Manufacturer within the European Economic Area and Türkiye
1. CE mark and legal requirements: Only correctly CE-marked medical devices may be placed on the Austrian market. Exemptions for CE-marking exist for devices for Clinical Investigations (Medical Devices) or Performance Evaluations (IVD) and for Custom Made Devices. The compliance with legal requirements according to the European regulatory framework, Austrian laws and harmonised standards is a further prerequisite.
2. Registration: The CE-marked medical device can be freely placed on the market in the EEA (and Türkiye) BUT has to be registered in the country where it was placed on the market for the first time.
- If your product is already on the market in a country within the EEA (and Türkiye) and correctly registered in the country where it was placed on the market for the first time, you do not need to register the product in Austria
- If you have a distributor located in Austria, the registration of your distributing partner within the Austrian Medical Devices Registry is obligatory.
3. Labelling and instructions for use: information on packages and in the patient leaflet etc. has to be in German, regardless of whether the target persons are lay or professional users. The manufacturer and/or the authorised representative have to be named on the package.
Manufacturer outside the European Economic Area (and Türkiye):
Steps 1-3, as described above, apply. Additionally,
4. Authorised representative (AR): A manufacturer located outside the EEA (and Türkiye) placing medical devices within the EEA, shall explicitly designate a single Authorised Representative within the area of the EEA (the AR has to be printed on the labelling and the instructions for use, more information can be found here. If the AR is based in Austria the AR has to register himself and the foreign manufacturer including its products at the Austrian Medical Devices Registry.
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.
The Austrian National Public Health Institute (GÖG) serves as the national contact point for EUDAMED in Austria.
Registration in EUDAMED is still voluntary for economic operators (manufacturers, system/procedure pack producers, authorised representatives, importers), but will be mandatory from the moment the European Commission announces that the database is fully functional.