Module 19 2021

24/05/2021

Transition from Directive to Regulation

New MDR DOA May 2021

Source: MHRA, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf

The Organisation for Professionals in Regulatory Affairs

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Increased regulatory scrutiny under IVDR

IVD directive ~15% of IVD’s require intervention of notified body

IVDR ~85% of IVD’s require intervention of notified body (All except Class A)

The Organisation for Professionals in Regulatory Affairs

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