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Recertification of legacy devices: extension of the transition period

On 6 January 2023, the European Commission submitted a proposal to extend the transitional period for the recertification of medical...

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...

Regulatory House

Implications of MDR on the availability of medical devices

The new legislation that came into force for medical devices in May 2021 has also presented difficulties. These include a lack of...