News

27/01/2023

HealthTech Industry Update | In Vitro Diagnostics Device IVD regulation implementation

Kurt Neubauer

Kurt Neubauer

As the Medical Device Regulation (MDR) updates, the In-Vitro Diagnostics Regulation (IVDR) was established to update the existing European Union In-Vitro Diagnostic (IVD) Device regulations.


The regulatory update of all market requirements for IVD devices led to the implementation of IVDR
in May 2017, with a transition period till 26th of May 2022.


The already tight timeline became even more challenging due to the COVID-19 pandemic.
The new IVDs and Class A non-sterile devices had still to comply with the IVDR from May 2022.


If you want to know more about:


➡️️ the new requirements


➡️ the challenge


➡️ the benefits


➡️ ️the transition


then here more details from the Med-Tech Innovation news…

https://www.med-technews.com/medtech-insights/medtech-regulatory-insights/navigating-ivdr-ahead-of-next-implementation-deadline/

If you would like to see more interesting posts, visit our knowledge database: https://thaumatec.com/knowledge/

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