European Commission on in vitro diagnostics. More availability is needed

- The priority of a strong European Health Union is to ensure that patients have access to medical devices and diagnostics whenever they need them. We must take immediate action to improve their availability. Today's proposal will provide assistance to the sector without compromising patient safety and care. Going forward, we are determined to analyze the root causes that are slowing down the transition, and we have committed to take appropriate action," says Stella Kyriakides, EU Commissioner for Health and Food Safety.

Ensuring the availability of diagnostics in vitro

In vitro diagnostics (IVDs) are tests used on biological samples to determine a person's health status, such as HIV tests, pregnancy tests or COVID-19 tests. The availability of safe and effective IVD medical devices is therefore essential for patient care. The regulation, which applies from May 2022, aims to modernize and modernize the EU framework for these products to ensure their safety for patients.

However, available data shows that a significant number of in vitro diagnostics currently on the market do not comply with the new regulations, nor have they been replaced by new devices. The situation is particularly critical for high-risk medical devices, which are devices used, for example, to test for blood and organ infections. To improve the availability of such essential devices, the EC is giving manufacturers more time to apply the new regulations under certain conditions, without compromising safety requirements. This is very important, also considering that many manufacturers producing in vitro diagnostic medical devices are small and medium-sized enterprises.

Under current regulations, the rules would apply from May 26, 2025 for high-risk in vitro diagnostic medical devices, or from May 26, 2027 for lower-risk in vitro diagnostic medical devices. The additional time granted to companies depends on the type of device:

• Devices with high individual and public health risks, such as HIV or viral hepatitis (Class D) tests, would have a transition period until December 2027;
• devices with high individual or moderate public health risks, 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 advance notice if they anticipate an interruption in the supply of in vitro diagnostic medical devices or medical devices, so that member states have more time to take action to ensure patient care.

Greater transparency in medical devices

Mandatory use of the European medical device database, EUDAMED, is crucial for the effective and efficient implementation of the medical device and in vitro diagnostic medical device regulations. It will increase transparency in the EU by providing an overview of all medical devices available on the European market. Today's proposal from the Commission aims to speed up the launch of the already finalized parts of the EUDAMED database so that it will be mandatory earlier (from the end of 2025).

Next steps

The proposal will now be submitted to the European Parliament and the Council for adoption.

The Commission will begin preparatory work on a targeted evaluation of medical device legislation as early as 2024. The assessment should examine how the legislation affects the availability of devices, particularly for devices with specific characteristics (e.g., pediatric devices, orphan devices, innovative devices). The assessment may also pay particular attention to the cost and administrative burden of implementing the legislation, especially for SMEs.

Elaborated. based on: press release