MDR Language Requirements in Austria
Austria is an EU-Member-State und therefore is obliged to implement the Medical Device Regulation MDR 2017/745 into national law. Medical device manufacturers should know the language requirements of each and every EU country if they plan to market their products in the European Union and since there are 24 official languages, it may be easy to get confused sometimes. Each Member State determines the languages accepted, but all must at least respect the country’s national language.
The Austrian Medical Devices Act (Medizinproduktegesetz) to implement the EU-MDR, came into force in July 2021 and was published by the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BSGPK – Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz). The BSGPK is responsible for the development of legislative frameworks as well as for strategic matters in the field of medical devices.
However, the competent authority in charge of medical device vigilance, clinical investigations, market surveillance and inspections as well as certificates of free sale is the BASG, the Austrian Federal Office for Safety in Health Care. As competent authority, the BASG, is the contact point for all medical device manufacturers.
So let’s take a look at the Austrian Medical Device Act 2021 (MPG) and the language requirements established by the government!
Índice de contenidos
Index of contents
Index du contenu
The language requirements are set out in paragraph 7, and split into seven subparagraphs. The Austrian implementation is very similar to the German language requirements regarding the differentiation between lay person use and professional use:
“Medical devices may only be supplied to the user or patient if the information supplied with the medical device is written in German. For medical devices the use of which is reserved exclusively for professional users, this information may also be in English.” – Art. 7(1), Medical Device Act 2021
Some information an IFU should include: Intended use, device description, precautions and warnings, manufacturer contact information.
The Declaration of Conformity (DoC) is an important part of the regulatory process for medical devices, in many countries. It serves as a declaration by the manufacturer that their product complies with the relevant regulatory requirements, ensuring its safety and performance. Besides general product and contact information, the manufacturer signs this document, declaring its conformity with all applicable national and European regulations.
In Austria the DoC is to be submitted in German:
The Federal Office for Safety in Health Care reserves the right to ask for any documentation to proof of compliance and conformity, and if that is the case, those documents must also be delivered to the competent authority in German.
“Upon a reasoned request by the Federal Office for Safety in Health Care, all information and documentation required to demonstrate the conformity of the product shall be provided in German.” – Art. 7(3), Medical Device Act 2021
Depending on the working language of your notified body (in charge of conformity evaluation), there might be a translation need for you.
There is one short and precise paragraph referring to the language requirement of the implant card in the Austrian law:
“The information to be provided by the manufacturer together with the implantable device pursuant to Art. 18 (1) of Regulation (EU) No. 745/2017 (implantation certificate) shall be provided in German.” – Art. 7(4), Medical Device Act 2021
No need to explain here.
According to Austrian law, the Field Safety Notice is to be send out to all users of the malfunctioning or defect medical device, in German. This also includes the corrective actions.
“The field safety notice pursuant to Art. 89(8) of Regulation (EU) No 745/2017 or Art. 84(8) of Regulation (EU) No 746/2017 shall be written by the manufacturer in German.” Art. 7(6), Medical Device Act 2021
All notified bodies are responsible for systematic and independent examination of processes, procedures, and records to determine if they comply with the applicable regulations and requirements. Notified bodies conduct audits of manufacturers' quality management systems and technical documentation to assess their compliance with the relevant standards and regulations.
This conformity assessment documentation is to be presented to the competent authority and according to Austrian law, there are only two linguistic options: German or English.
“1. pursuant to Art. 52 par. 12 of Regulation (EU) No. 745/2017 in connection with the procedures referred to in par. 1 to 7 and 9 to 11 of this article
2. in accordance with Art. 48 Para. 12 of Regulation (EU) No. 746/2017 in connection with the procedures referred to in Paras. 1 to 10 of this article in the German or English language.” – Art. 7(7), Medical Device Act 2021
In summary, adherence to the language requirements outlined in the Austrian Medical Device Act 2021 is crucial for medical device manufacturers planning to market their products in Austria. It is important to know the difference in language requirements between information for lay persons and healthcare professionals in countries like Austria, Germany or Greece. All stakeholders should be correctly informed about the language requirements determined by the member country.
To ensure accurate translations for medical devices and compliance with language requirements, medical device manufacturers are advised to collaborate with translation companies who are ISO 13485 certified. By engaging ISO 13485-certified language providers, manufacturers, distributors and importers can ensure accurate translations by professional translators with technical knowledge and experience in the medical field, facilitating compliance with the Austrian regulations and increase patient safety.
Other articles you may be interested in:
Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.