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Medical device regulations impacting international registrations

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Published on: 27 May 2020
Published by LNB News

LNB News 27/05/2020

Document Information

Issue Date: 27 May 2020

Published Date: 27 May 2020

Jurisdiction(s): United Kingdom

Article summary

MedTech Europe has analysed the impacts of changes under the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and Regulation (EU) 2017/745 on medical devices (MDR), recognising that both introduce major updates to the EU regulatory framework. IVDR presents several changes to the information provided with in vitro diagnostic devices and their regulatory documentation, meanwhile MDR amends the information provided with medical devices.

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Jurisdiction(s):
United Kingdom

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