Availability of EUROIMMUN products in the EU secured
On May 10, 2023, EUROIMMUN received the certificate for its quality management system according to the new European Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR) from TÜV Rheinland LGA Products GmbH. On the one hand, the certificate enables EUROIMMUN to also convert products of the higher IVD risk classes B and C from the old Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) to the new IVDR. On the other hand, new products in these classes can now also be marketed as IVDR-compliant. The company had already successfully declared its risk class A in vitro diagnostics as IVDR compliant in May last year.
“It is an outstanding team effort that we have now reached this major milestone in the transition from the old directive to the new IVD regulation” says Sven Bajorat, Head of the Division Quality Management and Regulatory Affairs at EUROIMMUN. “Despite some hurdles in the interpretation of the new regulation and in the interaction with the Notified Body, we managed with combined efforts to successfully implement the new requirements and to get the IVDR certificate.”
Successful conformity assessment of initial in vitro diagnostic products
A total of 30 initial in vitro diagnostic medical devices from various product groups in risk classes B and C have now been declared IVDR-compliant as part of the certification by TÜV Rheinland. These are in vitro diagnostics to support the diagnosis of infectious diseases, autoimmune diseases and allergies, for the detection of genetic markers, and software solutions for automated laboratory diagnostics.
The IVDR certificate has been a prerequisite for the sale of new in vitro diagnostic medical devices in risk classes B, C and D in the European Union (EU) since the IVDR came into force on 26 May 2022. It confirms that the extensive regulatory requirements are met by the respective manufacturer.
Further declarations of conformity will be made until the end of the transitional period
Due to transitional provisions of the new regulation, IVDD-compliant in vitro diagnostic products of risk class D can still be marketed until 26 May 2025, those of risk class C until 26 May 2026, and those of risk class B until 26 May 2027. In cooperation with TÜV Rheinland, EUROIMMUN will also convert the remaining products in due time and supplement the product portfolio with new, IVDR-compliant products.
This will ensure that laboratories in the EU can continue to use EUROIMMUN’s products without interruption.
With the successful acquisition of the IVDR certificate, EUROIMMUN confirms its commitment to always meeting the highest safety and performance standards for its products.