RISE is now a European reference laboratory for critical IVD products
01 October 2024, 06:03
As of October 1, RISE is a reference laboratory for medical devices for in vitro diagnostics, IVD. The European Commission has appointed the Swedish research institute RISE as reference laboratory for the area “Respiratory viruses that cause life-threatening diseases”.
- We look forward to working with notified bodies and manufacturers to ensure the quality and reliability of critical IVD products, says Benny Lyvén, director at the European reference laboratory at RISE.
The new EU regulation on in vitro diagnostic medical devices (IVDR) introduces new and stricter requirements for these products to enter the market - through increased controls and better traceability throughout the supply chain, making it safer for patients. With stricter regulations on in vitro diagnostics, all class D products to be used in diagnostics must be tested in a selected European reference laboratory.
- RISE is now one of only five reference laboratories in Europe, which means that we can contribute to raising health and safety standards throughout the EU. Class D is the highest risk class in IVD and includes products that can be used to diagnose serious diseases and conditions that pose a high risk to the patient if the results are incorrect, says Benny Lyvén from RISE.
In vitro diagnostics, IVD, means that a sample has been taken from the human body and then analyzed outside the body. This may be a blood sample or tissue sample, for example. Most IVD products are used by laboratories in the healthcare sector, but they can also be self-tests such as pregnancy tests or antigen tests for COVID-19.
Contact:
Benny Lyvén, RISE, benny.lyven@ri.se, +46 10 516 52 68