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  • Regulatory House

New law on medical devices and IVDs in force from 22.12.2022

At the end of 2022, the new common Law on Medical Devices and In Vitro Diagnostic Medical Devices No. 375/2022 was issued, repealing Law No. 89/2021 on Medical Devices and Law No. 268/2014 on In Vitro Diagnostic Medical Devices. The result is a consolidation and simplification as well as the addition of some information that was not previously fully described.

Its text together with other amended documents can be found in this link:

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