In Vitro Diagnostic Regulation

The IVDR regulation is set to replace the current directive on in vitro diagnostic medical devices (98/79/EC) in all European Union and EFTA member states. 

The regulation came into effect in 2017, and the industry was given a 5-year transition period (until May 2022) to meet the new requirements.

The combination of the increased standards and the impact of the recent COVID-19 pandemic has significantly affected the rate of transition activities to meet this deadline.

A key part of IVDR compliance as per article 56 and Annex XIII, is a thorough performance evaluation of the IVD.

The performance evaluation is a continuous process to demonstrate scientific validity, analytical and clinical performance of an IVD.

At Evnia, we provide IVDR services

    • to help you prepare your PEP and PER, ensuring that your in vitro diagnostic medical device will be in compliance with the General Safety and Performance Requirements, set in Annex I of IVDR
    • to guide you through the preparation of the respective Technical Documentation as per Annexes II & III of the IVDR

Read the Whitepaper: The in-vitro diagnostics Regulation (IVDR): Unravelling the challenges of the transition HERE

Contact us today by going to our contact page or call us at +45 88 82 57 97 to evaluate your needs towards achieving regulatory compliance.