EU Commission Proposes Extension of IVDR Compliance Deadlines
To ensure the availability of essential healthcare products, the European Commission has proposed an extension for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). This regulation, implemented in May 2022, seeks to modernize and upgrade the EU framework for in vitro diagnostics (IVDs) such as HIV tests, pregnancy tests, and COVID-19 tests.
However, data indicates that a significant number of IVDs currently on the market do not adhere to the new rules. The proposal allows manufacturers, especially small and medium-sized enterprises, to meet compliance standards without compromising safety requirements.
The transition periods vary based on the risk classification of the devices, ranging from high-risk devices with a transition period until December 2027 to lower-risk devices with a transition period until December 2029. From the commission’s January 23 press release:
“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), have a transition period until December 2029.
The proposal also requires manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices, so that Member States have more time to take action to ensure patient care.”
EU Commission Press Release – Brussels, 23 January 2024
At a glance —
The European Commission recently proposed an extension to the IVDR compliance deadline allowing manufacturers to meet standards without compromising safety requirements.
The additional time granted to companies depends on the type of device.
In addition to extending compliance timelines, the commission emphasizes transparency in the Medical Device sector. The proposal includes measures to expedite the launch of elements of the European Database on Medical Devices (EUDAMED), a crucial tool for effectively implementing the regulations. The accelerated implementation of EUDAMED, scheduled for late 2025, aims to enhance transparency in the EU by providing an overview of all medical devices available on the European market.
Asked for comment about the proposal, Joanne Lebrun, VP of Quality Systems at MDC, said, “It’s important to note that these extensions are not guaranteed, so we recommend that the industry continue to prioritize compliance with IVDR. If approved, the extension would provide time to catch up, not pause, on the transition of IVDs from IVDD to IVDR.”
The proposal will now undergo review by the European Parliament and Council for adoption. Simultaneously, the commission plans to initiate preparatory work in 2024 for a targeted evaluation of medical device legislation. This evaluation will assess the impact of the legislation on device availability, with special attention to devices with unique characteristics like pediatrics, orphan, and innovative devices. The assessment will also consider costs and administrative burdens, particularly for small and medium-sized enterprises. Medical devices play a crucial role in saving lives and providing innovative healthcare solutions for diagnosing, preventing, monitoring, and treating diseases.
If you have questions about how your product is classified or what rules apply to you, contact us.