Regulation (EU) 2017/745 on medical devices has significantly tightened the requirements for approval bodies: more extensive technical documentation, stricter medical validity testing, life cycle monitoring of products by the “Notified Body” and much more are required, as well as better qualified personnel. As a consequence, many of the admission offices stopped on the way to admission. The result: fewer than 50 approval bodies throughout Europe and (excessively) long waiting times for products that are either new to the market or need to be re-approved due to significant changes. In addition, more than 300,000 medical devices have to be recertified due to the provisions of the new EU regulation. This results in long waiting times, often many months, which is a significant disadvantage when you consider that the average life cycle of medical devices is 18-24 months. This obstacle to rapid market entry has now been removed.
QMS Services successfully certified
QMD Services has been officially authorized to carry out conformity assessments according to MDR since May 14, 2024. The approval for certifications according to IVDR was granted on December 23, 2022. This makes QMD Services one of only eleven approval bodies in the EU that processes both medical devices and in-vitro diagnostics - the customer base in Austria and beyond is growing. QMD Services, based in Vienna and Linz, is a subsidiary of Quality Austria - Trainings, Zertifizierungs und Begutachtungs GmbH. With QMD as an Austrian notified body, it is now easier for small and medium-sized companies and start-ups in the region in particular to obtain their CE mark and thus launch their new, innovative products on the market. There is also more capacity for the recertification of proven products. These are clear regional advantages and important building blocks for securing the medical technology ecosystem - a win-win situation for the companies and the healthcare sector. After all, what MedTech companies develop and manufacture is an integral part and cornerstone of our healthcare system. QMD is committed to ensuring that these products can be provided in high quality and do not disappear from the market. However, it is also important that new, innovative developments can unfold their potential and are approved quickly. This is absolutely essential for an intact and future-oriented healthcare system. Around 250 medtech companies are represented in Vienna, which together employ over 9,100 people and develop, produce or sell a wide range of medical devices and in-vitro diagnostics.
Certification capacities strengthen Vienna as a business and innovation location
“Vienna's economy is decisively shaped by pharmaceutical and medical technology companies. A notified body for medical devices is therefore of enormous importance and acts as a magnet for start-ups and SMEs in the medtech scene. In the economic and innovation strategy - Vienna 2030, this designation of QMD Services GmbH as a notified body was established as a flagship project and has been supported for many years. Vienna's exports will increase by EUR 2.25 billion as a result of the faster approval of domestic innovation, securing and creating 10,000 new jobs, but also generating up to EUR 400 million in tax revenue. As the person responsible for Vienna as a health metropolis, I cannot overestimate this success and congratulate all those involved for their tireless and consistent efforts,” says Alexander Biach, Vienna Business Location Attorney, responsible for the ‘Vienna as a metropolis of health’ theme in the ‘Vienna 2030’ economic and innovation strategy.
Gerhard Hirczi, Managing Director at the Vienna Business Agency, states: “Vienna has long been one of the best life sciences locations in the world. QMD Services’ approval as a new Notified Body for in-vitro diagnostics and medical devices is another milestone and strengthens the attractiveness of Vienna as a business location. It is highly relevant for international companies and start-ups, and for the numerous companies located in the region. Its combined expertise means a considerable advantage and paves the way for rapid market entry. The Vienna Business Agency and LISAvienna have actively supported the establishment of QMD Services from the very beginning.”
“We have put together a top-class team of international experts for this new responsibility,” says Anni Koubek, Managing Director of QMD Services. “They all have many years of experience in research, technology and medicine. This concentrated and international knowledge is now available to domestic companies for the conformity assessment of their products. We have thus become a central know-how hub for medical technology in Austria - and we are proud of it.” For Austrian companies in the medical technology sector, there is double added value, as QMD Services can issue certificates for both in-vitro diagnostics and medical devices. “Companies that conduct research and production in both areas will now find the responsibilities combined in just one single approval body in Austria. This puts an end to the search for a notified body somewhere in the EU. I am delighted that we can use our expertise to help strengthen this future market,” says Koubek, who is familiar with the concerns and special requirements of start-ups and small and medium-sized enterprises.
750,000 medical devices: Dynamic growth market
According to the latest figures from AUSTROMED, 750,000 medical devices are in use in Europe - in hospitals, doctors' practices and healthcare centers. These products range from latex surgical gloves, bandages, wheelchairs, pacemakers and knee or hip prostheses to high-tech X-ray machines and scanners. The medical technology sector stands for the highest level of innovation. Groundbreaking developments enter the market every year. 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. 7.6% of total healthcare expenditure (an EU average of 11% of GDP) is spent on medical devices. By comparison, the figure for pharmaceutical products is 15.4 percent (as of 2022). The entire European medical device market is estimated at more than 160 billion euros - after declines due to the economic crisis in 2009, growth in 2022 amounted to more than 11%. The highly dynamic and innovative nature of the market also shows that medical devices are replaced by newer ones after 18-24 months.
The MedTech Forum in Vienna for the first time
“The MedTech Forum” conference took place from May 23 to 24, 2024, where around 1,100 decision-makers from the European medical device and IVD industry met in Vienna to discuss current topics. LISAvienna and AUSTROMED acted as regional hosts. To kick things off, the conference guests were invited to a reception at Vienna City Hall, which was very well received. LISAvienna was also involved in designing the conference program: Top-class speakers provided insights into the characteristics of Vienna as a medtech location, the connection to international markets and how challenges in the cooperation between SMEs and large companies, investors or insurance companies can be overcome. On behalf of the Life Science Austria umbrella brand, LISAvienna organized a joint stand, where almost 40 companies from all over Austria and key players from the regional support landscape were represented. In total, a delegation of around 130 experts from across Austria took part in the conference at Messe Wien.
Vienna Business Agency: Healthcare Funding Program
Vienna’s science and business sector is particularly strong in the life sciences. The majority of the Vienna Business Agency’s new funding programs have the potential to advance Vienna as a metropolis of health. The Healthcare funding program is at the core of its new offering for the life sciences. It focuses on human health and supports companies in the development of new, groundbreaking solutions in areas ranging from prevention and diagnostics to therapy, rehabilitation and care. Is your company preparing a research project in the field of human health in Vienna? Are you working on products, processes or services to develop drugs, diagnostics or medical devices? Are you planning research projects in the fields of digital health and ambient assisted living? This funding program supports application and market-oriented R&D projects in the life sciences sector. Personnel costs, external services such as consulting, certification and IPR acquisition, and the purchase of machinery, systems, instruments and any necessary renovation and construction measures are eligible for funding.
- Up to €600,000 per project
- Women's bonus: €10,000
- Start-up bonus: €5,000
- Submission period: 1.4.-31.7.2024
Additional information is available here: https://viennabusinessagency.at/current-funding/healthcare-funding/
Save the date now: LISAvienna Regulatory Affairs Conference on October 17, 2024
With the eighth LISAvienna Regulatory Affairs Conference for Medical Devices and In-vitro Diagnostics, LISAvienna is once again promoting the exchange of knowledge on the implementation of MDR and IVDR and the requirements for approval in the USA and other countries. In addition to experts from notified bodies, research and healthcare institutions, successful companies and associations, we would once again like to make the perspective of the governmental authority responsible for these products visible. Around 400 participants are expected, first insights into the program will be published soon. Sign up for LISAvienna's free mailing service and follow us on LinkedIn to stay up to date.