Austria now has a Notified Body for in vitro diagnostic devices (IVD’s). After more than three years in preparation, 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 and Dr. Werner Paar.
Information event for manufacturers of IVD devices
On January 25, 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 at https://www.qmdservices.com/kickoffevent/.
QMD Services is from now open for applications under IVDR, with the scope as published in NANDO (Notified Body number 2962).
QMD Services GmbH (Ltd.)
QMD Services (Quality Medical Devices) was founded as a subsidiary of Quality Austria with the aim of becoming the first Austrian Conformity Assessment Body according to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) in December 2018. The company is headquartered in Vienna and has still another location in Linz. QMD Services has access to an international team with many years of experience in the industrial and healthcare sectors. QMD Services also benefits from the long-standing experience of Quality Austria in the field of certification of medical devices (ISO 13485). www.qmdservices.com
Quality Austria
Quality Austria - Trainings, Zertifizierungs und Begutachtungs GmbH is the leading Austrian contact point for system and product certifications, trainings and personal certifications. Quality Austria is accredited for system, product as well as personal certification by “Akkreditierung Austria” (Accreditation Austria) and has many international registrations and accreditations. Furthermore, Quality Austria presents the Austrian Excellence Award together with the Federal Ministry of Labour and Economy and awards the Austria Quality Seal. Quality Austria actively participates in standardization bodies and international networks, such as EOQ (European Organization for Quality), IQNet (International Certification Network) or EFQM (European Foundation for Quality Management). More than 10,000 customers in almost 30 countries and more than 6,000 training participants per year benefit from the many years of expertise of the internationally active company. Quality Austria also offers certifications for quality management systems upheld by manufacturers of medical devices. www.qualityaustria.com
Information
QMD Services GmbH (Ltd.)
Anni Koubek, CEO
Phone: +43-1-533 00 77
E-Mail: office(at)qmdservices.com
www.qmdservices.com
For press / public relations inquiries:
Wolf Mandl
Himmelhoch GmbH (Ltd.)
Phone: +43 676 774 33 28
E-Mail: wolf.mandl@himmelhoch.at
For press / public relations inquiries:
Mag. Doris Lenhardt
Himmelhoch GmbH (Ltd.)
Phone:+43 650 400 27 81
E-Mail: doris.lenhardt(at)himmelhoch.at