New EU rules and regulations came into effect on May 26, 2022, to regulate in vitro diagnostic device that uses biological samples to determine a person’s health status.
These include pregnancy tests, COVID-19 tests as well as laboratory tests that are performed at the time of blood donations.
The new rules and regulations are meant to reflect advances in technology and prioritise patient safety and public health. Regulations include establishing a new risk-based classification system, an EU medical device database as well as performance data collection.
According to a European Commission release, about 70 percent of clinical decisions are made using in vitro diagnostic medical devices.
Moreover, these devices are used for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases.
Along with this, the Commissioner of Health and Food Safety, Stella Kyriakides, mentioned in the statement, “Today we are marking a big step forward for the patients and the diagnostics industry in the EU. The pandemic of COVID-19 has highlighted the significance of accurate and safe diagnostics, and having stricter rules in place is a key element in ensuring this is the case for EU patients.”
The regulations introduce oversight by notified bodies and independent third-party conformity assessment bodies to improve the quality as well as safety of tests.
In addition, a database for 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 to make the information on the device more accessible and transplantable.
Furthermore, Devices that are marked as high-risk will be more closely monitored and controlled with a new pre-market scrutiny mechanism with a pool of experts at the European Union level, according to the European Commission.
