The EU regulation 2017/2017 for in vitro diagnostic devices (IVDR) published in 746 was intended to increase safety for patients. Due to the stricter requirements, the number of products requiring approval has multiplied, since significantly more in-vitro diagnostics now require a conformity assessment, for which no conformity assessment was required under the old regulation. This new legal framework led to longer development times and higher costs for all manufacturers of IVD products, but also changed the criteria for the testing bodies. “The lack of notified bodies is striking! For the conformity assessment of IVDs there are only eight bodies available throughout Europe - with QMD Services. It has now been possible to bring Austria back into an excellent market position and to establish a notified body as an important element of the health infrastructure,” outlines QMD Services Managing Director Dr. Anni Koubek the difficult situation.
Lengthy approval process
After the application was submitted in October 2019, the subsidiary of Quality Austria, QMD Services, went through a complex process under the direction of the Austrian authorities and the EU Commission. The approximately 600 Austrian companies from the medical device industry now have a national contact again. QMD Services has been authorized to carry out conformity assessment activities for in vitro diagnostic devices since 23.12.2022/19/XNUMX. This means that, for example, laboratory tests for blood and urine samples, pregnancy and blood sugar tests, PCR and antigen tests for diagnosing COVID-XNUMX and much more can be certified directly in Austria in the future. “The preparation time alone shows how complex this topic and the European legal test procedure is. Since QMD Services was not previously active as a Notified Body for the previous legislation, we are all the more pleased that we, as a newcomer, have obtained a designation as an IVD Conformity Assessment Body,” emphasizes dr Anni Koubek. The company is also in the approval process according to the Medical Devices Ordinance 2017/745 and expects the process to be completed in the course of 2023.
Broad support for the project
The project was made possible by Quality Austria, an internationally renowned Austrian certification and training company that founded QMD Services (Quality Medical Devices) in December 2018. “For us as owners, this project is an enormously important step in innovation. This will establish a competitive infrastructure, service proximity and domestic premium quality for the Austrian healthcare system, which many companies have been waiting for," emphasize the Co-managing directors of Quality Austria, Mag. Christoph Mondl and Dr. Werner couple. The establishment of the Notified Body for IVD was supported by the federal states of Vienna, Upper Austria, Lower Austria, Styria and Tyrol.
Voices from the funding federal states
Peter Hanke, Vienna City Councilor for Economics and Finance: “As a world-class location for business and life sciences, Vienna benefits enormously from this approval. The city is Austria's most important life science location, around half of all local companies are based here. The newly created certification capacities ensure that start-ups and SMEs from the industry will receive an appointment for the intensive testing process that is necessary before entering the market more quickly in the future. This increases the attractiveness of Vienna, especially for international life sciences companies and start-ups who want to settle in Vienna. The in-vitro diagnostics developed and produced in the city are thus available more quickly and safely and can save lives. We are pleased that our experts from the Vienna Business Agency and LISAvienna were able to support the development of QMD services right from the start, thereby further strengthening the health and business metropolis of Vienna.”
Markus Achleitner, Economics and Research Provincial Council of Upper Austria: “Medical products are examples of success for local high-tech companies, and a national contact point is of enormous importance for the economy. As early as 2019, I took the initiative to bring an approval body for IVDs to Upper Austria together with the company QMD Services. That's why I'm very pleased that Upper Austria has once again become a pioneer, precisely because many companies in the medical technology sector are based here. Established companies and start-ups thus have ideal conditions in Upper Austria to successfully implement innovations.”
"Lower Austria has not only recognized the potential of health technologies as a future-oriented topic since the pandemic. Both the Technopol program launched in 2004 and the ecoplus platform for health technology support the innovation ecosystem in the areas of research, education and business. The establishment of a notified body in Austria makes a significant contribution to the economic success of the Lower Austrian diagnostics and medical device manufacturers. New high-tech jobs will be created in the health sector and the security of supply for the local population will be strengthened in the long term Lower Austria's Economic Provincial Mag. Jochen Danninger.
“The establishment of a national approval body for in-vitro diagnostics cannot be overestimated. This is not only a milestone for the domestic medical industry, but also strengthens our business and innovation location. I am very pleased that Styria was able to contribute to this success and that with managing director Anni Koubek, a Styrian woman is steering the fortunes of QMD Services. I would like to congratulate them warmly and wish them every success in their work,” she emphasizes Styrian Minister for Science and Economy MMag.a Barbara Eibinger-Miedl.
Mario Gerber, Tyrolean Provincial Councilor for Tourism, Economy and Digitization, emphasizes the importance of medical technology as a whole and of in-vitro diagnostics products in particular for Tyrol: “In-vitro diagnostics are part of the growing medical technology sector in Tyrol. It is very gratifying that with QMD Services a Notified Body according to IVDR can now operate - one of eight in the whole of Europe! This can support efficient approval as part of a speedy market entry for in-vitro diagnostics. This contributes to the attractiveness of Austria and thus also of Tyrol as a life sciences location, but also to the security of care for patients.”
QMD Services is now accepting applications for certification under IVDR with the in NANDO (Notified body Number 2962) published scopes.
Information event for IVD manufacturers
Am January 25, 2023 from 16:00 p.m. to 18:00 p.m
QMD Services is hosting an online information event
for all interested representatives from the industry.
QMD Services GmbH
QMD Services GmbH (Quality Medical Devices) was founded in December 2018 as a subsidiary of Quality Austria with the aim of making European Notified body for medical devices and in vitro diagnostics in Austria after the EU Regulations (EU) 2017/745 and 2017/746 to become.
The company has its headquarters in Vienna and another location in Linz.
QMD Services has access to an international team with many years of experience in the industrial and healthcare sectors.
QMD Services also benefits from Quality Austria's many years of experience in this area Medical Device Certification (ISO 13485).
Contact
QMD Services GmbH
Anni Koubek, Managing Director
Tel: 01-533 00 77
office@qmdservices.com
www.qmdservices.com
