New EU IVDR: Finalise your documentation and stay ahead of the game!
In 2021, the new In vitro diagnostic medical devices Regulation (2017/746/EU) was postponed to May 26, 2022.
However, due to the ongoing disruption caused by the Covid-19 pandemic, the European Commission proposed a scaled roll-out to give manufacturers and operators time to comply with the new regulations. Nevertheless, we 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. Depending the risk classification of the test involved, the new IVDR will take effect in May 2025, 2026, or 2027. Despite this breathing time, it is still important to start the transition as soon as possible.
The compliance transition period is starting at the end of this month.
Get your documentation ready now and do not wait until the last minute!