Devyser’s quality management system and fetal diagnostic product are approved under the new European IVD regulation

STOCKHOLM , August 29, 2022 /PRNewswire/ — Devyser has today been certified under the new, more comprehensive IVD regulations which came into force on May 26, 2022. The certification, issued by the notified body TÜV SÜD, covers the quality management system and the diagnostic product Devyser’s fetus. The approval strengthens Devyser’s position in the market and confirms the company’s long-term focus on quality and patient safety.

From May 26, 2022, all new medical devices intended to be sold in Europe will have to comply with the new IVD regulation which defines reinforced quality and safety requirements for the diagnostic use of medical devices in order to ensure the highest level of public health protection. For a product to meet the requirements, the company’s quality management system must, among other things, be certified in accordance with the regulations.

“We have worked intensively over the past two years to meet the more comprehensive requirements of the IVD regulations. Our customers can take comfort in knowing that our fetal diagnostic product has already been approved. Additionally, it shows that Devyser has a development and quality organization capable of competing with the best in Europe,” says Fredrik Alpsten, CEO of Devyser.

In Europe, in vitro diagnostic medical devices must be CE marked in accordance with Directive 98/79/EC of the European Parliament and of the Council in order to be marketed. The new regulation, known as IVDR (EU) 2017/746, replaced the previous directive on May 26, 2022, meaning products must undergo a new approval process. Devyser’s fetal diagnostic product has been approved under the new regulations and the company is now certified to continue registering new and existing products under the new European regulations.

“The transition to the IVD regulation is a major challenge for the industry in general. This certification is a sign of our relentless commitment and focus on quality and patient safety. We are proud to be able to offer this assurance to our customers,” said Theis Kipling, CCO of Devyser.

This is information that Devyser Diagnostics AB (publ) is required to publish in accordance with European Regulation 596/2014 on market abuse. The information was submitted for publication by the contact persons below on August 29, 2022 at 2:30 p.m. CET.

For more information please contact:

Fredrik Alpsten, CEO [email protected] Telephone: +46 706 673 106

Sabina Berlin, Chief Financial Officer [email protected] Telephone: +46 739 519 502

About Devyser Diagnostics AB (publ)

Devyser develops, produces and sells genetic test kits to laboratories in over 45 countries. The products are used for advanced DNA testing in the fields of hereditary diseases, oncology and transplantation, to enable targeted cancer treatment, diagnosis of a large number of genetic diseases and follow-up of transplant patients. . Devyser’s products simplify complex genetic testing processes, improve sample throughput, minimize hands-on time, and deliver fast results. The company was founded in 2004 and is based in Stockholm, Sweden.

Devyser shares are listed on Nasdaq First North Growth Market Stockholm (ticker: DVYSR). The company’s certified advisor is Redeye AB. For more information, visit www.devyser.com.

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SOURCE Devyser Diagnostics AB

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