RISE to evaluate products for in vitro diagnostics

 "We are of course very pleased with the positive message from the EU. In addition to ensuring the performance of products, we also see the opportunity, through our infrastructure and expertise, to strengthen pandemic preparedness in Sweden and the EU for future crises similar to the Covid-19 pandemic and to be able to be a hub in the identification and management of any new, unknown infectious threats," says Benny Lyvén, business developer in medical technology at RISE.

The new EU Regulation on in vitro diagnostic medical devices (IVDR) introduces new and more stringent requirements for these products to enter the market - through increased controls and better traceability throughout the supply chain, making it safer for patients. With a stricter regulatory framework for in vitro diagnostics, all Class D products to be used in diagnostics must be tested in a selected European reference laboratory.

In vitro diagnostics (IVD) means that a sample has been taken from the human body and then analyzed outside the body. This could be a blood or tissue sample, for example. Most IVD products are used by healthcare laboratories, but they can also be self-tests such as pregnancy tests or antigen tests for COVID-19.

Stricter requirements have been introduced for so-called notified bodies, an independent institute that reviews the quality and safety of products in higher risk classes. The notified bodies are appointed by the authorities and assess whether the products can be approved and thus sold. In the EU, there have only been six such institutes for IVD products, making it difficult for companies to get hold of a notified body.

RISE has been appointed as a reference laboratory for Class D products to be used in diagnostics and is one of two laboratories in Europe selected to evaluate in vitro diagnostic products for the diagnosis of virus-borne upper respiratory tract infections.

 "We will assist notified bodies in producing data on class D IVD products. 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.

RISE already has the expertise and infrastructure to handle risk-classified products and has good experience of accredited operations and quality work, which ensures high quality in sample handling. The reference laboratory at RISE will participate in networks across Europe to harmonize and develop reference methods and contribute expertise on IVD products to the European Commission. In autumn 2024, RISE will be able to receive class D products, but already now a new service is offered: analysis of blood groups according to an accredited method.

Contact:

Benny Lyvén, RISE, benny.lyven@ri.se, +46 10 516 52 68