In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine the status of a person's health. There is a broad range of IVDs. Some examples are self-tests for pregnancy, COVID-19 tests, cancer genetic tests or high-throughput testing of blood donations for infections such as HIV, performed in clinical laboratories.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices replaces Directive 98/79/EC and significantly reinforces the regulatory framework for these medical tests. The Regulation applies since 26 May 2022.
It was adopted together with the more general Regulation (EU) 2017/745 on medical devices, which has been applicable since 26 May 2021 (more information on the New Regulations web page).
In summary, Regulation (EU) 2017/746 introduces three important advances:
- Improves the quality, safety and reliability of IVDs with a new risk-based device classification system, more detailed and stringent rules on the evaluation of device performance, and greater involvement of independent conformity assessment bodies ('notified bodies'). New scientific bodies such as a panel of IVD experts and EU reference laboratories can be involved in the assessment of the highest-risk devices.
- Strengthens transparency and information for patients, so that vital information is easier to find. The European database of medical devices (Eudamed) will contain information about all in vitro diagnostic medical devices on the market, including economic operators and certificates issued by notified bodies. A unique device identifier will be mandatory for every product so that it can be found in Eudamed. For medium- and high-risk devices a summary of safety and performance will be made publicly available.
- Enhances vigilance and market surveillance: Once devices are available on the market, manufacturers have to collect data about their performance and EU countries will closely coordinate their vigilance and market surveillance activities.
Regulation (EU) 2022/112 amended the transitional rules, allowing for a progressive roll-out of the new framework. Moreover, common specifications are adopted for particular types of devices. The work on IVDs is also supported by guidance documents endorsed by the Medical Device Coordination Group.