The new In Vitro Diagnostic Regulation (IVDR) 2017/746 is a set of regulations issued by the European Union (EU) for the control and supervision of in vitro diagnostic medical devices (IVDs).
These regulations aim to improve the safety and effectiveness of IVDs and ensure that they are of high quality.
The IVDR has been applicable since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for high-risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions.
To be prepared for the IVDR, there are several steps that manufacturers, distributors, and other stakeholders can take: Familiarize yourself with the requirements of the IVDR. Make sure you understand the requirements of the IVDR and how they apply to your organization and products.
Verify your device classification according to the IVDR new classification system as you may now require the involvement of a Notified Body.
Review your current processes and procedures. Ensure that your processes and procedures for developing, manufacturing, and distributing IVDs comply with the requirements of the IVDR.
Develop a plan for transitioning to the IVDR, including timelines and budgets.
Consider seeking assistance from a third party, such as a regulatory affairs consultancy, to help you navigate the transition to the IVDR.
Keep up to date with developments in the IVDR and any changes or updates to the regulations.
By following these steps, you can ensure that your organization is prepared for the IVDR and can continue to provide high-quality IVDs to patients.
Contact US for further support and guidance.
This article was prepared by:
Dr. Einat Dekel, DVM
QA & RA Medical Device Senior Consultant,
SME In-Vitro Diagnostics & Digital Health
