In July 2022, the European Commission opened its call for Member States to submit applications for EU reference laboratories. The call is for EU Member States as well as for Iceland, Norway, Liechtenstein, and Turkey. EU Reference Laboratories (EURLs) are scientific laboratories within the European Union designed to ensure the safety and compliance of IVDs with the IVD Regulation. In fact, this is one of the most relevant changes that the new In Vitro Diagnostic Medical Devices Regulation (IVDR) brought.
Requirements and Applications
The criteria for the EU Reference Laboratories include, among others, requirements for staff, equipment used, standards and best practices, administrative organization, public interest, and confidentiality.
Some of the areas from which Laboratories can apply are:
- Hepatitis and retroviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
- Blood grouping
Do you want to know more about the new IVDR? Contact us to stay always up to date!