European Parliament | Proposal for a Regulation amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices


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Regulation (EU) 2017/746 of the European Parliament and of the Council establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. It is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices.

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