The EU Regulation 2017/746 on in-vitro diagnostic medical devices (IVDR), published in 2017, was intended to increase patient safety. Due to the stricter requirements, the number of products requiring approval has multiplied, as significantly more in-vitro diagnostic devices now require conformity assessment, something that was not required under the previous regulation. This new legal framework has led to longer development times and higher costs for all manufacturers of IVD products, but it has also changed the criteria for the notifying bodies. "The shortage of notified bodies is glaring! For the conformity assessment of IVDs, there are only eight bodies available in all of Europe – including QMD Services. We have now succeeded in restoring Austria to an excellent market position and establishing a notified body as a crucial element of the healthcare infrastructure," explains Dr. Anni Koubek, Managing Director of QMD Services, outlining the challenging starting point.
Lengthy approval process
Following its application in October 2019, Quality Austria's subsidiary, QMD Services, underwent a complex process overseen by the Austrian authorities and the European Commission. Now, the approximately 600 Austrian companies in the medical device sector once again have a national point of contact. Since December 23, 2022, QMD Services has been authorized to conduct conformity assessment activities for in-vitro diagnostics. This means that, for example, laboratory tests for blood and urine samples, pregnancy and blood glucose tests, PCR and antigen tests for diagnosing COVID-19, and much more can now be certified directly in Austria. "The preparation time alone demonstrates the complexity of this topic and the European regulatory review process. Since QMD Services was not previously a Notified Body under the preceding legislation, we are all the more pleased to have been designated as an IVD conformity assessment body as a newcomer," emphasizes Dr. Anni Koubek . The company is also in the approval process under the Medical Device Regulation 2017/745 and expects a positive conclusion to the procedure 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, which founded QMD Services (Quality Medical Devices) in December 2018. "For us as owners, this project is an enormously important step forward in innovation. It establishes a competitive infrastructure, proximity to service, and premium domestic quality for the Austrian healthcare system, something many companies have been urgently awaiting," emphasize Quality Austria's co-managing directors, Christoph Mondl and Werner Paar. The establishment of the Notified Body for IVDs was supported by the federal states of Vienna, Upper Austria, Lower Austria, Styria, and Tyrol.
Voices from the funding federal states
Peter Hanke, Vienna's City Councillor for Economic Affairs and Finance : "As a world-class business and life sciences hub, Vienna benefits enormously from this accreditation. The city is Austria's most important life sciences location, home to around half of all domestic companies. The newly created certification capacities ensure that startups and SMEs in the sector will be able to obtain appointments more quickly for the intensive testing process required before market entry. This increases Vienna's attractiveness, especially for international life sciences companies and startups looking to establish themselves in Vienna. In-vitro diagnostics developed and produced in the city will also be available more quickly and reliably, potentially saving lives. We are delighted that our experts from the Vienna Business Agency and LISAvienna were able to support the development of QMD Services from the outset, further strengthening Vienna as a health and business metropolis."
Markus Achleitner, Regional Minister for Economic Affairs and Research of Upper Austria: “Medical devices are success stories for domestic high-tech companies, and a national contact point is of enormous importance to the economy. Back in 2019, I took the initiative to bring an IVD approval authority to Upper Austria together with the company QMD Services. Therefore, I am very pleased that Upper Austria has once again become a pioneer in this field, especially since many medical technology companies are based here. Established companies and start-ups thus have ideal conditions in Upper Austria to successfully implement innovations.”
“Lower Austria recognized the potential of health technologies as a forward-looking field long before the pandemic. Both the Technopol program, launched in 2004, and the ecoplus Health Technology Platform support the innovation ecosystem in the areas of research, education, and business. The establishment of a Notified Body in Austria significantly contributes to the economic success of Lower Austrian diagnostics and medical device manufacturers. New high-tech jobs in the healthcare sector are being created, and the long-term security of supply for the local population is being strengthened,” said Lower Austria’s Minister for Economic Affairs, Jochen Danninger.
“The establishment of a national regulatory authority for in-vitro diagnostics cannot be praised highly enough. This is not only a milestone for the domestic medical sector, but also strengthens our economic and innovation base. I am delighted that Styria was able to contribute to this success and that a Styrian, Anni Koubek, is at the helm of QMD Services. I offer my warmest congratulations and wish her every success in her new role,” emphasized Barbara Eibinger-Miedl, Styrian Minister for Science and Economic Affairs.
Mario Gerber, Tyrol's Regional Councillor for Tourism, Economy and Digitalization , emphasizes the importance of medical technology in general and in-vitro diagnostic products in particular for Tyrol: "In-vitro diagnostics are part of the growing medical technology sector in Tyrol. It is very gratifying that QMD Services, a Notified Body under the IVDR, can now begin operations – one of only eight in all of Europe! This will support efficient approval as part of a rapid market entry for in-vitro diagnostics. This contributes to the attractiveness of Austria, and thus also of Tyrol, as a life sciences location, as well as to the security of supply for patients."
QMD Services is now accepting applications for certification under IVDR with the scopes published in NANDO (Notified body Number 2962).
Information event for IVD manufacturers
On January 25, 2023, from 16:00 PM to 18:00 PM
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 long-standing experience in the field of certification for medical devices (ISO 13485).
Contact
QMD Services GmbH
Anni Koubek, Managing Director
Tel: 01-533 00 77
office@qmdservices.com
www.qmdservices.com