On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The Comission noted that its goal in revising the deadline is to ensure patient care by improving the availability of these essential healthcare products. The Commission is also proposing measures to enhance transparency in the Medical Device sector including by speeding up the launch of some elements of the European Database on Medical Devices (EUDAMED), so that it is mandatory as of late 2025.
The proposal was driven by recent data showing that a considerable number of in vitro diagnostics currently on the market do not yet comply with the new rules and have not been replaced by new devices. The situation is especially critical for high-risk IVDs used, for example, to test for infections in blood and organ donations.
Under the current provisions, these rules would apply from May 26, 2025, for high risk IVDs or May 26, 2027, for lower risk IVDs. The additional time granted to companies depends on the type of device:
- high individual and public health risk devices such as HIV or hepatitis tests (class D) would have a transition period until December 2027
- high individual and/or moderate public health risk devices such as cancer tests (class C) would have a transition period until December 2028
- lower risk devices (class B such as pregnancy tests and class A sterile devices such as blood collection tubes) would have a transition period until December 2029
The proposal also requires manufacturers to give prior notice if they foresee an interruption of supply of IVDs or medical devices, so that Member States have more time to take action to ensure patient care.
“A priority of a strong European Health Union is to ensure that medical devices and diagnostics are available to patients, whenever they need them. We must take immediate action to improve their availability,” said Stella Kyriakides, Commissioner for Health and Food Safety. “Today’s proposal will provide relief for the sector, without compromising patient safety and care. Going forward, we are determined to analyze the root causes that slow the transition and are committed to take appropriate action.”
The Proposal will now be put forward to the European Parliament and Council for adoption.