Medical devices: After 7 years there is another approval body in Austria

There is again an approval body for medical devices in Austria. QMD Services, a subsidiary of Quality Austria, has been available as a so-called notified body for a week. The 620 domestic manufacturers of medical devices in particular have been waiting for this day because proximity is important to them, reported Anni Koubek, Managing Director of QMD Services, at a press conference in Vienna.

According to Austromed, there are around 750,000 medical devices in use in Europe, with possible approvals ranging from blood collection tubes and surgical masks to knee prostheses to monitoring monitors for intensive care units and X-ray machines. “We are only one of eleven notified bodies in Europe that are allowed to test medical products and in-vitro diagnostics, i.e. laboratory tests,” explained Koubek.

Advantage for companies

“This week we have already had inquiries from eight European countries,” she reported, including from Austria. “We see that Austrian companies value proximity.” This reduces travel costs and also the common language and the fact that QMD Services is familiar with the Austrian Medical Devices Act simplifies the approval process. QMD Services now operates an office in Vienna and one in Linz.

The more than 620 domestic medical device manufacturers employ around 62,000 people. It is an “important location policy issue that we get a national approval authority,” said Upper Austria’s Minister for Economic Affairs Markus Achleitner (VP). In Upper Austria, 62 companies in the industry employ around 7,300 people.

In 2016 and 2017, the two previous notified bodies for medical devices in Austria expired and EU regulations were tightened to increase patient safety. Austria needs to be back in this niche, which is why the states of Upper Austria and Vienna in particular have supported the project. In total, the approval body will cost around 1.4 million euros, it was said at the press conference.