The new legislation for the CE marking of IVDs (In Vitro Diagnostics) came into force in 2017 (EU 2017/746): this legislation includes a review of all the validation procedures and documentation that are useful for the CE-IVD marking. 

Thanks to the new rule, in 2022 the self-referenced markings will no longer be valid and greater importance will be given to the clinical validation process and clinical trials. 

CoQua Lab has a commercial partnership with the only European laboratory certified UNI EN ISO 9001 e 13485 (CE-IVD): this affords to help you in the clinical trial preparation and its submission to the Ethics Committee, following you in each step also collecting specimens that are needed for the device validation.