New EU IVDR: Time is running out! Is your life science company ready?
The new regulation on In vitro diagnostic medical devices Regulation (2017/746/EU) was postponed last year to 26 May 2022.
This new deadline gave manufacturers and operators some extra time to achieve compliance with the new regulations. Nevertheless, we would still advise everyone involved in the industry to start their processes and evaluations in order to avoid possible capacity issues for Notified Bodies.
The IVDR aim to improve product transparency and traceability and to create a less complex trading environment between EU member states by regulating the market with clearer rules. The manufacturers will have to comply with the IVDR by May 2022. It’s important to start the transition as soon as possible.
Get your documentation ready!