The Proposed Amendments to MDR and IVDR | MedTech Voices

Device Advice by RQM+

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4M ago 14:47

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Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal.

All current transition timelines have been extended by 2.5 years with new deadlines ranging from 31 December 2027 for highest risk devices to 31 December 2029 for the lower risk devices.

There are some conditions around these transition deadlines, including:

No significant changes can be made to the device
PMS and vigilance requirements under IVDR must be met
An IVDR compliant QMS must be implemented by 26 May 2025
An application must be lodged with the notified body at least two years ahead of the transition deadlines

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