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No More Guessing On Device Scrutiny: EU Regulatory Texts now Out

This article was originally published in SRA

Executive Summary

The consolidated texts of the EU's medical device regulation and IVD regulation are now publicly available on the website of the European Parliament, two weeks earlier than expected1. And the publication of the documents mean companies can know with certainty how they might be impacted by the new rules, particularly concerning thorny issues such as the scrutiny of high-risk devices.

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