New EU rules will come into effect today, 26 May, to regulate in vitro diagnostic medical devices, any diagnostic device that uses biological samples to determine a person’s status of health. These include pregnancy tests, Covid-19 tests and laboratory tests performed during blood donations.
The new rules 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 and guidelines for performance data collection.
According to a European Commission news release, around 70% of clinical decisions are made using in vitro diagnostic medical devices. These devices are used for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases.
“Today we are marking a big step forward for the patients and the diagnostics industry in the EU,” Stella Kyriakides, Commissioner of Health and Food Safety, said. “The Covid-19 pandemic has underlined the importance of accurate and safe diagnostics, and having stronger rules in place is a key element in ensuring this is the case for EU patients.”
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The regulations introduce oversight by notified bodies, independent third party conformity assessment bodies, to improve the quality and safety of tests.
Eudamed, a database for medical devices, will contain information about all in vitro diagnostic medical devices on the market, including economic operators and certificates issued by notified bodies to make information on the devices more accessible and transparent.
Devices 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 EU level, according to the European Commission.