Module 15 2022

5/19/2022

MDD

MDR Overview

MDD

MDR

• 60 Pages (MDD only) • 23 Articles • 12 Annexes • 13 Essential Requirements to be fulfilled D=Directive : Legislation that sets out rules and must be transposed into national law to be effective

• 175 Pages (MDD + AIMD) • 10 Chapters, 123 Articles • 17 Annexes • 23 GSPR to be fulfilled

Medical Device Directive vs. Medical Device Regulation

R=Regulation: Mandatory Jurisdiction that is directly applicable and enforceable in all EU Member States

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© NAMSA 2021

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MDR Goals

“Regulations pave the way to a more patient-friendly environment, where transparency and patients' information and choice are a priority; where patients can benefit from innovative, highly performing devices and new therapies become possible.”

EU Commission Factsheet April 2017

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© NAMSA 2021

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