Module 16 2022

9/2/2022

• MDR Regulatory Framework, Requirements and Key Changes

The EU MDR is the European Union Medical Device Regulation 2017/745 that was published in May 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR regulations is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.

This new regulatory framework is intended to be a regulatory framework for medical devices that can sustainably ensure health & safety while still encouraging innovation.

TOPICS

https://advisera.com/13485academy/what-is-eu-mdr/

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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MDR Regulatory Requirements and Key Changes

D=Directive: Legal Act that sets out conformity assessment rules and must be transposed into EU Member state national law to be effective.

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

1 Ratified Version April 05 th , 2017

Source: https://medicaldevicehq.com/articles/new-in-the-2017-745-mdr/

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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