amjs澳金沙门(中国)有限公司

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2024年5月22日
国家医疗器械公告机构
自5月中旬以来，随着QMD Services的加入，奥地利拥有了自己的国家医疗器械公告机构。

从左到右的图像：Christian Schweiger博士（实验医学专家，amjs澳金沙门主席），Philipp Hainzl（LISAvienna首席执行官），Anni Koubek博士（QMD Services首席执行官），Markus Achleitner（上奥地利经济事务省议员），Hagen Pleile（WKO联邦工业部门副总经理，OQA主席） © Jana Madzigon
无论是外科口罩、绷带、膝关节假体还是X射线设备：对于620多家国内制造商的产品而言，拥有62000名员工的巨大市场准入优势。

56个月——这就是复杂的审查和批准过程所花费的时间，但自5月14日起，一切尘埃落定：奥地利拥有了自己的国家合格评定机构（“公告机构”），即QMD Services，Quality Austria的子公司。背景：在欧盟医疗器械法规及其新的、更严格的要求之后，许多公告机构退出，国内公司不得不在欧盟内寻找（更少的）合格评定机构。结果：等待时间很长——通常是几个月。这在考虑到医疗器械的平均生命周期为18-24个月之后会被新和更好的设备取代时，这是一个劣势。这一“快速进入市场”的障碍现已得到解决。而且：QMD Services是整个欧盟范围内仅有的11家同时被指定为医疗器械和所谓的体外诊断产（即生物样本的医疗诊断产品）的公告机构之一。

“凭借我们顶尖的国际专家团队，拥有多年在研究、技术和医学领域的经验，我们已经成为奥地利医疗器械的核心知识中心——我们对此感到自豪。现在，这些集中知识可供国内公司用于其产品的合格评定，”QMD Services的董事总经理Anni Koubek博士说。“这为欧盟内外的制造商在选择公告机构时提供了额外的选择。我很高兴我们能利用我们的专业知识来帮助加强这个充满活力的未来市场。”

医疗器械：增长的动态市场
根据AUSTROMED的最新数据，欧洲有750,000种医疗器械正在使用。这些器械包括乳胶外科手套、绷带、轮椅、起搏器、膝盖或髋关节假体以及高科技X射线机和扫描仪。2022年，欧洲专利局注册了15,600件医疗器械。相比之下，“仅”有9,300件药品专利和8,100件生物技术专利被提交。

整个欧洲医疗器械市场的估值超过1600亿欧元——在2009年经济危机导致的下滑之后，2022年的增长超过了11％。

医疗器械作为就业引擎：奥地利在欧盟范围内的员工数量排名前三
目前，奥地利有626家公司制造医疗器械，直接和间接雇用了62,000人（根据AUSTROMED）。按人口计算，这使奥地利在欧盟中排名第三（仅次于爱尔兰和荷兰）。包括间接和诱导效应在内，国内医疗器械市场产生了186亿欧元的价值——且这一趋势在上升。

为创新的奥地利中小企业提供中小企业专业知识
根据联邦劳动和经济部的数据，99.8％的奥地利公司是中小企业（SME）——因此，医疗器械行业中的92％的公司（根据MedTech Europe）也是中小企业。对于他们的产品批准来说，关键是：一个“公告机构”，如QMD Services，了解中小企业的结构、关注点和特点，并在整个批准过程中加以考虑。

一站式服务：QMD Services现在是医疗器械和体外诊断产品的公告机构
奥地利医疗技术领域的公司现在拥有双倍的附加值。自2022年12月底以来，QMD Services一直是体外诊断产品（即生物样本的医疗诊断产品）的公告机构，并且自5月中旬以来，现在也是医疗器械的审批机构。

22. May 2024
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, Chairpersonamjs澳金沙门), 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.