MDR & IVDR national implementation: Austria

The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in vitro diagnostic medical devices in Austria. The Austrian Federal Office for Healthcare (BASG) lists all legal basis applying for healthcare products, which might present additional requirements to those set by the EU legislation.

Among others, the Austrian Medical Device Act (Gesamte Rechtsvorschrift für Medizinproduktegesetz 2021) defines rules about national registration, medical devices fee, language requirement, determination procedures, ethics commission, and liability in case of accidents.

National registration in Austria

National registration in Austria is mandatory, and there are no fees associated. Overall, national registration is mandatory for the three following groups:

1. Persons and companies, including manufacturers, importers, authorised representatives, sterilising companies, and system manufacturers based in Austria.
2. Natural and legal persons placing on the market medical devices (including in-vitro diagnostics and custom-made medical devices) for the first time in the European Economic Area.
3. Certifiers, testing laboratories, and inspection bodies of medical devices based in Austria.

Concerning device registration, if the manufacturer placed a medical device in another EU country and registered it in the respective national database, it is not necessary to register again in the Austrian Registry.

The Austrian Medical Devices Registry provides further information on registration obligations in Austria.

Registration and PRRC

The Manufacturer must provide details on the PRRC, in German Für die Einhaltung der Regulierungsvorschriften verantwortliche Person, when registering as an actor. Notably, the data provided must be in conformity with Article 15 of both Medical Devices Regulation and IVD Medical Devices Regulation.

Medical devices fees

According to the Medical Devices Fee Ordinance, every person or company placing medical devices on the Austrian market to end users shall pay an annual fee to the Federal Office for Safety in Healthcare (BASG). The Annex of the Ordinance lists the amount or assessment of the medical device fee, which differs based on the risk class of the device.

Language requirements on labels and IFUs: German

According to Annex II of both MDR and IVDR, patients or users can only use medical devices and IVD medical devices if the information accompanying the medical device is in the languages accepted by the Member State concerned. Precisely, the information accompanying the medical device in Austria must be in German. However, this information may also be written in English for medical devices intended exclusively for professional users.

Classification procedures of the Competent Authority

Upon request of the manufacturer or the Authorised Representative, the Austrian Federal Office for Safety in Healthcare must determine device’s classification. Especially, the Competent Authority establishes if the device falls under the scope of the Regulation – MDR or IVDR – and if the classification is correct.

Within the framework of this procedure, the Competent Authority shall obtain an opinion of the Delimitation and Classification Advisory Board. Specifically, Article 2 of the Austrian Medical Device Act defines the tasks and requirements of the Delimitation and Classification Advisory Board.

Ethics commission for clinical trials and performance studies

Each state of the Austrian Federal Republic shall have an independent ethics commission. In particular, it is necessary to involve an ethical commission according to the Federal Law on hospitals and health care centres when clinical studies or performance studies are performed in hospitals or health care centres.

Moreover, when applying for a clinical trial, the sponsor shall submit to the ethics committee all the necessary documents for the assessment of the clinical trial. Particularly, the sponsor shall submit:

• Proof of qualification and trial plan
• Proof of safety of the medical device
• Preclinical documents and results of the benefit/risk analysis
• Materials to inform the participants and to obtain their consent
• Documents on data security and compliance with the data protection regulations
• Documents about the insurance and compensation for the participation

Article 3 of the Austrian Medical Device Act defines the requirements and functions of the ethics commission.

Nonetheless, if a clinical trial has no authorization or notification according to the applicable legislation, it will not be possible to publish the data obtained, forward them to third parties, and use them for a conformity assessment procedure or an approval procedure.

Liability in case of incidents

Adverse incidents with medical devices and IVD medical devices have to be reported, either online or on paper, to the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen).

Eventually, if there is reasonable suspicion that a medical device caused health damage or death, the healthcare facility – or the person who uses or operates medical devices professionally or commercially – is obliged to take the legal position of the patient to safeguard the enforcement of any liability claims.

Check out our map and read about national requirements in EU countries!

 

References:
BASG. (2022). Medical devices fee. Retrieved on 01/12/2022.
BASG. (2021). Gesamte Rechtsvorschrift für Medizinproduktegesetz 2021, Fassung vom 05.12.2022. Retrieved on 05/12/2022.
BASG. (2002). Verordnung des Bundesamtes für Sicherheit im Gesundheitswesen über die Einhebung, Entrichtung und Festsetzung der Höhe einer Medizinprodukteabgabe. Retrieved on 01/12/2022.
BASG. (2001). Gesamte Rechtsvorschrift für Krankenanstalten- und Kuranstaltengesetz, Fassung vom 05.12.2022. Retrieved on 05/12/2022.
Rechtsinformationssystem des Bundes. (2014). Gesamte Rechtsvorschrift für Medizinproduktemeldeverordnung, Fassung vom 07.03.2014. Retrieved on 01/12/2022.