Communication from QMD services GmbH
Notified Body for in vitro diagnostics and medical devices
QMD Services was founded in December 2018 as a subsidiary of Quality Austria - Trainings, Zertifizierungs und Begutachtungs GmbH with headquarters in Vienna and Linz. Since December 2022, QMD Services has been a conformity assessment body under the In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) with the identification number NB 2962. The designation procedure according to the Medical Devices Regulation (EU) 2017/745 (MDR) at the Federal Ministry of Social Affairs, Health, Care and Consumer Protection is still ongoing.
Milestone for securing the site
Thus, after seven years of vacancy, Austria again has a national regulatory body for in vitro diagnostics (IVD). After three and a half years of preparation, QMD Services received the approval as a European conformity assessment body according to the In Vitro Diagnostics Regulation. Domestic manufacturers of products for medical diagnosis of biological samples now once again have a national contact point. For the Austrian medical device industry, this is an important milestone in securing the location. This was supported by the federal states of Vienna, Lower Austria, Upper Austria, Styria and Tyrol.
The EU In Vitro Diagnostics Regulation (IVDR) 2017/746, published in 2017, was intended to increase safety for patients. Due to the stricter requirements, the number of products requiring approval has multiplied, as significantly more in vitro diagnostic devices now require a conformity assessment for which none was required under the old regulation. This new legal framework led to longer development times and higher costs for all manufacturers of IVD products, but also changed the criteria for the reviewing bodies.
"The lack of Notified Bodies is striking! For the conformity assessment of IVDs, there are currently only ten bodies available in all of Europe – including QMD Services. Here we have now succeeded in bringing Austria back into an excellent market position and establishing a Notified Body as an important element of the healthcare infrastructure," QMD Services Managing Director Dr. Anni Koubek outlines the difficult initial situation.
National focal point
After the application was submitted in June 2019, Quality Austria's subsidiary QMD Services went through a complex process under the procedural guidance of the domestic authority and the EU Commission. Now, the more than 500 Austrian companies from the medical device industry once again have a national contact. QMD Services has been authorized to perform conformity assessment activities for in vitro diagnostic devices since December 2022. This means that laboratory tests for blood and urine samples, pregnancy and blood glucose tests, PCR and antigen tests for the diagnosis of COVID-19 and much more can be certified directly in Austria in the future.
"The preparation time alone shows how complex this topic and the European legal testing procedure is. Since QMD Services has not been active as a Notified Body for the previous legislations before, we are very pleased that we, as a newcomer, have obtained a designation as an IVD Conformity Assessment Body," emphasizes Dr. Anni Koubek.
The project was made possible by Quality Austria, which founded QMD Services (Quality Medical Devices) in December 2018. "For Quality Austria, this project is an important innovation step. With it, a relevant infrastructure for the Austrian healthcare system can be established, which the companies have been urgently waiting for. In addition, this also provides more independence from foreign accreditation bodies for the domestic medical sector, which in turn eliminates a location disadvantage that has existed for years," emphasize the Co-Managing Directors of Quality Austria, Christoph Mondl and Dr. Werner Paar.
Companies that would like to make use of the services of QMD Services are kindly requested to contact office@qmd-services.com. The responsible contact persons at QMD Services will then immediately prepare your conformity assessment procedure for IVDR or inform you about the procedure for MDR.
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