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 internet website www.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 (cf. Question No. 3). Registrations have to be kept up-to-date by the user.
Who has to register with the Austrian Medical Devices Registry?
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.
What is the legal basis for registration?
According to the Austrian Act on Medical Devices (Medizinproduktegesetz), and according to European Directives concerning medical devices and in-vitro diagnostics (90/385/EEC, 93/42/EEC, 98/79/EC, amended by 2007/47/EC), Austria is obliged to maintain a registry of medical devices. The Austrian Public Health Institute (GÖG) was commissioned by the Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) to run and maintain the registry (since 2002). The scope of information to be entered into the Austrian Medical Devices Registry is regulated in the Austrian Ordinance on the notification of medical devices and in-vitro diagnostics (Medizinproduktemeldeverordnung).
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 Switzerland) 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 distribution partners situated in Austria, it is strongly recommended that they register with the Austrian Medical Devices Registry (though not obligatory).
Are there any fees associated with the registration with the Austrian Medical Devices Registry?
No, there are no fees associated with the registration. The Austrian Medical Devices Registry operates as 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 here.
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 and cannot view data of other users.
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 EU market (or Switzerland) 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, Switzerland:
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 Switzerland) 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 Switzerland) 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 situated in Austria, the registration of your distributing partner within the Austrian Medical Devices Registry is voluntary but strongly recommended.
3. Labelling and instructions for use: According to the Austrian Act on Medical Devices MPG § 9 Abs. 6 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 Switzerland):
Steps 1-3, as described above, apply.
4. Authorised representative: 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.
- If the Authorised Representative (AR) is seated in Austria and the products are placed on the Austrian market for the first time within the Common Market, the AR has to register with 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
Austromed (the special interest group of medical devices manufacturers and distributors)
LISA Vienna (the joint life science platform)
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:
Individual sickness funds negotiate contracts and tariffs with medical device manufacturers and distributors. No uniform application process exists. Generally, medical devices are reimbursed if listed in a reimbursement catalogue established by each sickness fund and prescribed by a medical practitioner. If they are listed, depending on the sickness fund of the patient concerned, patients either receive the device without having to pay anything (or only a partial contribution), or they have to pay for it and are reimbursed afterwards by their sickness fund.
For 80% of the products, a coordinating institution (Competence Center Heilbehelfe / Hilfsmittel (CC HBHI) helps with reimbursement recommendations (for a specific group of devices according to an annual work plan) and also leads negotiations with interest representations of specific professions. Several expert committees conduct economic and qualitative evaluations of applied devices and provide recommendations to sickness funds which are in charge of taking the reimbursement decisions.
Medical devices are included in the lump sums which can be generated for reimbursement of the procedure and diagnosis-orientated case groups (DRG) in hospitals (“Leistungsorientierte Krankenanstaltenfinanzierung – LKF”). Some, mostly highly innovative medical devices, are exceptions in the DRG lump sum system, since these medical devices are recorded in their own diagnosis-orientated case groups (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?
Currently, there are no notified bodies operating in Austria. However, all notified bodies in Europe can be found on the NANDO website: http://ec.europa.eu/growth/tools-databases/nando/.
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 (online or paper-based form) to the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen).
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 according to Article 40 of the Medical Devices Act. More information can be found here.
What is EUDAMED and why are my products entered into this database?
EUDAMED is the European Database for Medical Devices which was established by the European Commission and aims to help European authorities conduct market surveillance on medical devices through information exchange. The Austrian Public Health Institute (GÖG) also serves as the national contact point for EUDAMED, regarding data of manufacturers, authorized representatives and devices in Austria and data relating to certificates issued in Austria.