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The In Vitro Diagnostic Medical Devices Regulation is here—a closer look at what you need to know

Published on: 25 May 2022
Published by a LexisNexis EU Law expert
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Article summary

Life Sciences analysis: The In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746) becomes applicable on 26 May 2022. Lisa Page, partner, and Mary-Clare Palmer, associate, at Penningtons Manches Cooper take a deep-dive into what changes are introduced, discuss serious challenges to and impact of its implementation on the heels of last year’s Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and analyse the wider sector impact for EU medical device access and innovation. They also provide a helpful breakdown of the recently amended transitional provisions further to its guidance and consider what next for manufacturers with devices on the market in Europe and the UK.

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