National Notified Body for medical devices
With QMD Services, Austria has its own national Notified Body for medical devices since mid-May
Image from left to right: Dr. Christian Schweiger (Specialist for laboratory medicine, ChairpersonOQS), Philipp Hainzl (CEO LISAvienna), Dr. Anni Koubek (CEO QMD Services), Markus Achleitner (Provincial Councillor for Economic Affairs of Upper Austria), Hagen Pleile (Deputy Managing Director WKO Federal Industry Division, Chairperson OQA) © Jana Madzigon
Whether surgical masks, bandages, knee prostheses or X-ray equipment: Enormous market access advantage for the products of more than 620 domestic manufacturers with 62,000 employees
56 months - that's how long the complex review and approval process took, but since May 14th, it's a done deal: Austria has its own national conformity assessment body ("Notified Body") for medical devices in the form of QMD Services, a subsidiary of Quality Austria. The background: Following the EU Medical Devices Regulation and its new, stricter requirements, many notified bodies withdrew and domestic companies had to look for (fewer) conformity assessments bodies in the EU. The result: long waiting times - often many months. A disadvantage when you consider that the average life cycle of medical devices is 18-24 months before they are replaced by new and better ones. This obstacle "on the fast track to the market" has now been femediated. And: QMD Services is one of only eleven Notified Bodies in the entire EU designated for both medical devices and so-called in-vitro diagnostics, i. e. products for the medical diagnosis of biological samples.
"With our top-class team of international experts with many years of experience in research, technology and medicine, we have become a central know-how hub for medical devices in Austria - and we are proud of it. This concentrated knowledge is now available to domestic companies for the conformity assessment of their products," says Dr. Anni Koubek, Managing Director of QMD Services. "This gives an additional alternative for choosing a notified body to manufacturers in and outside the EU. I am delighted that we can use our expertise to help strengthen this dynamic future market."
Medical devices: Dynamic market with growth
According to the latest figures from AUSTROMED, 750,000 medical devices are in use in Europe. These range from latex surgical gloves, bandages, wheelchairs, pacemakers and knee or hip prostheses to high-tech X-ray machines and scanners. In 2022, 15,600 medical devices were registered with the European Patent Office. By comparison, "only" 9,300 patents were filed for pharmaceuticals and 8,100 for biotechnology.
The entire European medical device market is estimated to be worth more than 160 billion euros - after declines due to the economic crisis in 2009, growth in 2022 amounted to more than eleven percent.
Medical devices as a job engine: Austria in the top three EU-wide in terms of employees
626 companies currently manufacture medical devices in Austria, employing 62,000 people directly and indirectly (according to AUSTROMED). In terms of population, this puts Austria in third place in the EU in this sector (after Ireland and the Netherlands). Including indirect and induced effects, the domestic medical device market generates 18.6 billion euros - and the trend is rising.
SME know-how for innovative Austrian SMEs
According to the Federal Ministry of Labor and Economy, 99.8 percent of Austrian companies are small and medium-sized enterprises (SME) - consequently, 92 percent of companies (according to MedTech Europe) in the medical device industry are also SMEs. Central for them in the approval of their products: A "Notified Body", such as QMD Services, which knows the structure, concerns and special features of small and medium-sized companies and also takes them into account throughout the entire approval process.
One-stop store: QMD Services now Notified Body for medical devices AND in-vitro diagnostics
Austrian companies in the medical technology sector now have double the added value. QMD Services has been a Notified Body for in-vitro diagnostics, i. e. products for the medical diagnosis of biological samples, since the end of December 2022 and has now also been an approval body for medical devices since mid-May.
