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On track towards IVDR certification of our product portfolio


IVDR | March 21, 2023

Devyser announced in Aug 2022 that we received our first IVDR certificate from the notified body TÜV SÜD. The certification applies to our Quality Management System and Devyser Compact, our rapid prenatal testing for chromosomal disorders.   

The EU Quality Management System Certificate (IVDR) is mandatory for manufacturers of in vitro diagnostic devices (IVDs) to issue declarations of conformity for products and to get them (re-)certified in compliance with the new regulation.   

Obtaining the IVDR certificate represents a crucial milestone and accomplishment for our company, as it highlights our unwavering dedication to meeting the rigorous standards set by the regulation.  

Commitment to patient safety 

Our commitment to patient safety is reflected in every aspect of our operations, from the way we develop and test our products to the way we train our employees and collaborate with healthcare providers. By earning this certification, we are proud to show that we are meeting the rigorous standards set by industry experts, and provide safe, reliable, and effective solutions for our customers and their patients. Patient safety has been core to our mission since Devyser was founded almost 20 years ago.  

IVDR – a top priority 

We are transitioning our product portfolio to the new regulation (IVDR) in alignment with timelines provided by the European Commission. We are fully committed to continuing servicing diagnostic labs, healthcare professionals, and ultimately patients, worldwide with our high quality, reliable and accurate tests.    

- IVDR is a top priority for our management, and we have been fully committed from the beginning. I feel confident with our progress so far, says Olle Myrberg, Head of QA/RA and PRRC at Devyser. We are on track and have a clear process in place and a dedicated team working with this and a good relationship with our notified body, TÜV SÜD Product Service GmbH. 

Our first IVDR compliant product, Devyser Compact, was launched in March. 

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