Commission proposes extending in vitro diagnostics implementation timeline

The European Commission released on Tuesday (23 January) a proposal to review the timelines for companies to comply with the In Vitro Diagnostic Medical Devices Regulation to ensure availability and avoid shortages.

In-vitro diagnostic (IVDs) medical devices are tests used on biological samples to determine the status of a person’s health, ranging from self-tests for pregnancy to diagnoses performed in clinical laboratories.

These devices are ruled by a regulation applicable since May 2022 aiming to modernise and upgrade the EU framework for these products to ensure patient safety.

A year and a half after the regulation entered into play, most companies are struggling to reach the deadline, which could cause shortages if uncertified devices end up out of the market. 

“From the data available, we see that the transition from the existing rules to the new rules is lower than expected, and we want to ensure that there is time to secure the availability of the device,” a Commission official told reporters during a press briefing. 

As the main manufacturers of these devices are SMEs, the official added it is particularly challenging to meet the requirements in time especially when it comes to high-risk in-vitro diagnostics – the ones used to test infections in blood and organ donations, among others. 

In practice, this extension guarantees manufacturers approximately two additional years until the rules start to apply. With the new provisions and depending on the type of device, the end of the transition period will range from 2027 for high individual and public health risk devices to 2029 for lower-risk devices. 

According to the Commission, these new timelines are not a “blank check”. “We have a number of conditions that the manufacturer has to comply with to also demonstrate the willingness and the transition to the new rules, which have been set out for enhancing patient safety”, explained the same Commission official. 

Together with the time extension, the Commission proposed a prior notice requirement with the same objective of supporting availability. This mechanism will ensure that hospitals and other competent authorities are well prepared to face availability challenges. 

The proposal states that manufacturers, distributors and other relevant actors would need to notify any possible interruption of supply at least six months in advance.

[Edited by Zoran Radosavljevic]

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