A new position paper on the class D measures in the absence of EURLs
On October 5, 2022, the European Association for Medical Devices of Notified Bodies (Team NB) published a new position paper in connection with the implementation of the regulations on medical devices and on in-vitro diagnostics.
In June 2022, the European Commission launched a call for applications for EURLS (EU Reference Laboratories) in several product categories; a designation is planned for Q3 2023. However, it is currently unknown whether EURLs will be determined for all device categories.
This position paper aims to provide a framework for the verification process for Class D IVD medical devices by Notified Bodies (NB) in the absence of EU Notified Reference Laboratories (EURLs).
The scope includes verification during the review of the technical documentation before certification as well as of manufactured products after certification.
This position paper examines possible solutions and/or preliminary implementation measures. However, it is entirely up to a notified body to decide what methods and solutions to use if they wish to follow up class D applications without EURLs. Therefore, contact your notified body at an early stage.