New IVD regulation

European laboratories and clinicians are facing significant changes in diagnostic tests. The IVDR (In Vitro Diagnostics Regulation) will be the new regulation for in vitro diagnostics in Europe.

At Invitek Molecular, several products fall within the scope of IVDR implementation. We have planned for this transition and are currently working across our various departments to ensure that Invitek is IVDR-ready in due course. For our products the IVD Regulation becomes effective from May 26, 2022.


What does the IVDR include?

A new risk classification system in accordance with international guidelines

Stronger oversight of the Notified Body

New clinical evidence requirements

Improved transparency through a comprehensive new EU database for medical devices (EUDAMED)

Strengthened requirements for post-market surveillance and post-market performance follow-up


Which Invitek products are affected by the new IVDR?

All products affixed with a CE-IVD mark are affected by the IVDR.


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