Module 16 2024

10/17/2024

MDR Regulatory Framework, Requirements and Key Changes

The EU-MDR is the European Union Medical Device Regulation 2017/745 and has replaced the former EU-Medical Device Directives (MDD & AIMDD) 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 dev ices that are produced in, or distributed in the the European Economic Area (EEA).

This new EU regulation is the current European regulatory framework for medical devices intended to sustainably ensure patient health & safety while still encouraging medical device innovation.

TOPICS

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

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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MDR Regulatory Framework, Requirements and Key Changes

TOPICS

2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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