Milestone for the Medical Device Industry
QMD Services obtains designation as a Notified Body for in vitro diagnostic devices
Austria now has a Notified Body for in vitro diagnostic devices (IVD’s). After more than three years in preparation, qualityaustria subsidiary QMD Services obtained designation as a European conformity assessment body according to the In Vitro Diagnostic Regulation on December 23rd, 2022.
The EU Regulation 2017/746 “In Vitro Diagnostic Regulation” (IVDR), published in 2017, is specifically designed to help increase safety for patients. As the requirements have become more stringent, the number of devices that are subject to conformity assessment by a Notified Body has increased significantly. This new legal framework has not only led to longer development times and higher costs for all manufacturers of IVD devices but has also changed the criteria for the conformity assessment bodies.
“There is still a drastic shortage of notified bodies for IVDs! All over Europe, no more than eight bodies - including QMD Services - are available as bodies assessing conformity of IVD devices.” This is how Dr. Anni Koubek, CEO of QMD Services, describes the current situation.
Lengthy and tedious designation process
QMD Services (a subsidiary of Quality Austria) filed an application for designation in October 2019. The company then went through a complex designation process, led by the national competent authority and the EU Commission. Following successful listing on NANDO on December 23rd, 2022, QMD Services is now entitled to carry out conformity assessment activities (CE Marking) for in vitro diagnostic devices. This means that European manufacturers for IVDs such as tests on blood or urine samples, pregnancy tests, blood sugar tests or COVID-19 tests, etc. can now be certified by this Austrian organisation.
The company is also going through a similar designation process under the Medical Device Regulation 2017/745 for general medical devices and hopes to receive designation in the course of 2023.
Broad support of the project
The project was enabled and facilitated by Quality Austria, an internationally renowned certification and training company. This company founded QMD Services (Quality Medical Devices) in December 2018. QMD Services received public support from the Austrian regions Vienna and Upper Austria as well as from Lower Austria, Styria, and Tyrol.
“For us as owner, the project is a very important development step. This project helps to establish a competitive infrastructure, relevant service proximity and premium quality for the Austrian healthcare system, which the device manufacturers have been yearning for a long time.” This is emphasised by the joint CEOs of Quality Austria, Christoph Mondl (right) and Dr. Werner Paar (left).
Information event for manufacturers of IVD devices
On January 25th, 2023, at 4 pm, QMD Services will organise an on-line information event for all representatives of the industry that are interested (in German language). Free registration is possible here.
QMD Services is from now open for applications under IVDR, with the scope as published in NANDO (Notified Body number 2962).
Don't miss it!
Register here for the free on-line QMD Services information event on January 25th, at 4 pm!