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.
The Commission has observed that the transition from the existing rules to the new ones is slower than expected. To address this, they have proposed an extension that gives manufacturers approximately two additional years before the rules start to apply. Depending on the type of device, the end of the transition period will vary from 2027 for high-risk devices to 2029 for lower-risk devices.
The Commission has emphasized that these new timelines are not a “blank check”. Manufacturers must comply with several conditions to demonstrate their commitment to transitioning to the new rules, which are designed to enhance patient safety.
In addition to the time extension, the Commission has proposed a prior notice requirement to support availability. This will ensure that hospitals and other competent authorities are well-prepared to handle availability challenges.
