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An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)

 MHRA-GOV.UK
  15th-May-2018
Description: Navigate through the topics listed along the bottom of each page using the buttons on either side of the document.
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Domain: Medical
Category: Implants
Contributing Organization: MHRA-GOV.UK
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Contents:
An introductory guide to the medical device regulation (MDR)
and the in vitro diagnostic medical device regulation (IVDR)

mhra.gov.uk

devices.implementation@mhra.gov.uk

1
Introduction

Definitions

Classification

Conformity
assessment

Placing a
device on the
market

UDI and Eudamed

Supply chain
obligations

PMS and vigilance

Contact

Introduction - How to use this guide

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