IVDR certificate for test kits for the identification of infectious diseases
QMD Services: First in-vitro diagnostics certificate achieved in record time
Image: QMD CEOs Ing. Florian Heffeter, EUR ING (FEANI), BSc., LL.M., and Dr. Anni Koubek © Jana Madzigon
Certificate issued within just nine months; further success: requests for medical device certification from eight countries after just three weeks
The first in-vitro diagnostics certificate (IVDR) was achieved in a record time of just over nine months: At QMD Services, things are progressing rapidly. The subsidiary of Quality Austria - Trainings, Zertifizierungs und Begutachtungs GmbH, which is based in Vienna and Linz, has been operating as Notified Body for in-vitro diagnostics (such as laboratory tests for blood or urine samples, blood glucose tests, PCR tests, etc.) since the end of December 2022 and now issued the first certificate for the Turkish company Anatolia Geneworks on May 27th, 2024. In addition, on May 14th, QMD Services has been designated as Notified Body for medical devices and is now one of only eleven companies in Europe covering both regulations. In just three weeks, the only Austrian certification body received conformity assessment inquiries from eight European countries.
“Certification normally takes 12 to 18 months,” says Florian Heffeter, CEO of QMD Services. "We are proud that our team - with all the care and the highest quality - managed to complete this in just over nine months. This is the best advertisement for QMD Services as a Notfied Body for the whole of Europe, and the international interest confirms this."
“Anatolia has achieved a significant milestone by obtaining its first EU Quality Management System certificate. This achievement underscores Anatolia's commitment to maintaining the highest standards in molecular diagnostics,” says Dr. Elif Akyuz, Vice President of Anatolia Geneworks. “We are aware of our huge responsibility, as well as our contribution to the healthcare. We see the IVDR transition period as a great opportunity to further enhance our quality. This certificate was granted following a meticulous set of audits conducted by the EU-authorized Notified Body QMD Services GmbH, we appreciate their professionalism and challenging us with their competent auditor team.”
First IVDR certificate for PCR kits for the identification of infectious diseases
The first IVDR certificate issued by QMD Services to Anatolia Geneworks covers devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents.
Booming market: QMD Services shortens “time to market”
Laboratory tests for blood or urine samples, blood glucose tests, X-ray devices, pacemakers, artificial prostheses - IVDs and medical devices are an integral part of modern healthcare and the market is booming accordingly. There are 750,000 medical devices in use in hospitals and health facilities. The system faces a particular challenge: due to the industry's high level of innovation, products are replaced by new, improved ones every 18 to 24 months. Long waiting times at notified bodies can therefore delay market entry.
"With QMD Services, Austria now again has a certification body for IVDR and MDR, which is a huge advantage for hundreds of domestic companies in this sector. The great international interest also demonstrates the need for notified bodies in general,” says Florian Heffeter.
