Proposal to prolong implementation timeline for in vitro diagnostics by Commission (Health & Beauty - Health Services)

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Proposal to prolong implementation timeline for in vitro diagnostics by Commission


The European Commission has proposed a review of the compliance timelines for the In Vitro Diagnostic Medical Devices Regulation. This move is aimed at ensuring the availability of these devices and preventing potential shortages.

In-vitro diagnostic (IVD) medical devices are tests performed on biological samples to assess a person’s health. These range from self-tests for pregnancy to diagnoses conducted in clinical laboratories. The regulation governing these devices has been in effect since May 2022, with the goal of modernizing and enhancing the EU framework for these products to ensure patient safety.

However, a year and a half into the implementation of the regulation, many companies, especially SMEs who are the main manufacturers of these devices, are finding it challenging to meet the deadline. This could lead to shortages if uncertified devices are removed from the market.

For more details please visit our website - https://www.medhealthinsight.com/new-soundboard-review-pricing-is-not-always-the-only-criteria-2-7/

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Target State: New York
Target City : New York City
Last Update : Sep 26, 2025 2:20 AM
Number of Views: 49
Item  Owner  : medhealthinsight
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