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…
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