The European Commission (EC) has proposed an extension of the transition period for the IVDR, aiming to maintain the availability of essential healthcare products and ensure patient care.
The revision also includes measures to enhance transparency in the medical device sector.
In vitro diagnostics (IVDs) are designed to provide essential health status information through tests on biological samples.
Effective since May 2022, the IVDR seeks to modernise the EU framework for these products.
However, many IVDs on the market are yet to comply with the new regulations.
In a press statement, the EC said: “To improve the availability of such essential devices, today’s proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements.
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“This is very important, also taking into account the fact that many manufacturers producing IVDs are small and medium-size enterprises [SMEs].”
The extended deadlines vary by device risk category: high-risk devices like HIV tests until December 2027, moderate-risk devices like cancer tests until December 2028 and lower-risk devices until December 2029.
The proposal will now advance to the European Parliament and Council for adoption.
Commissioner for Health and Food Safety Stella Kyriakides said: “A priority of a strong European Health Union is to ensure that medical devices and diagnostics are available to patients, whenever they need them.
“Today’s proposal will provide relief for the sector, without compromising patient safety and care. Going forward, we are determined to analyse the root causes that slow the transition and committed to take appropriate action.”
The EC plans to start preparatory work in 2024 for a targeted assessment of the medical devices legislation, focusing on device availability and the impact on SMEs.