In Vitro Diagnostic Medical Device Regulation (IVDR)

The acronym IVDR stands for In Vitro Diagnostic Medical Device Regulation that entered into force on the 26th of May 2017 as replacement of In Vitro Diagnostic Directive 98/79/EC (IVDD).

Manufactures of CE marked in vitro diagnostic products have been given a time frame of 5 years to align their products with the new guidelines. You can find the official EU regulation document here.

As respected and valued manufacturer of in vitro diagnostic devices, Eureka Lab Division is committed to keep high standards quality products and to satisfy all the requirements of the European market.

We are engaging to face such transition to the new requirements, that are expected by IVDR 2017/746 issued by the European Commission (CE), in order to prepare an appropriate documentation according to the new classification system.

The purpose of the new regulation

The IVDR comes from the need to increase safety and efficiency in the EU medical device market.

Our aim

Eureka Lab Division is committed to produce excellent and highly competitive IVDR compliant products meeting the European market requirements to offer an increasingly safety to all customers.