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MedTech Europe announces new in vitro diagnostic symbols to comply with IVDR

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Published on: 22 October 2020

Published by LNB News

LNB News 22/10/2020

Document Information

Issue Date: 22 October 2020

Published Date: 22 October 2020

Jurisdiction(s): United Kingdom

Article summary

MedTech Europe has announced new in vitro diagnostic (IVD) symbols for compliance with Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). IVD devices will transition to the IVDR by 26 May 2022, and the regulation requires devices intended for self-testing, for near-patient testing and specific rapid tests to state these facts on their labels. MedTech Europe has proposed the symbols to ensure that the intended user of a device is clear, and it also removes the need to translate the indication to all EU languages. MedTech Europe has also issued IVD symbols titles translations for self-test and near-patient tests.

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