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Proposed amendment to the EU’s MDR and IVDR

January 2023 Regulatory Affairs Watch

On Friday, 6 January 2023, the European Commission published a proposal for an amendment to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The amendment aims to prevent the threat of supply bottlenecks and interruptions after the end of the transition period.

Source: European Commission