Public health: New rules on in vitro diagnostic medical devices (IVDR) enter into force
As of May 26, 2022, new rules embedded in Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) have entered into force.
The new rules aim to :
• improve the quality, safety, and reliability of IVDR devices through a risk-based classification system
• strengthen transparency and information for patients, so that pertinent information is more easily found.
• enhance vigilance and market surveillance: once devices are available on the market, manufacturers will collect data about device performance. EU Member States will coordinate their vigilance and market surveillance actions.
This new Regulation replaces older Directive 98/79/EC and supports the regulatory framework for medical tests. This Regulation will be implemented gradually with transition periods that vary and depend on the risk level of each device. This Regulation complements the Regulation 2017/745 on medical devices. Nearly 70% of clinical decisions are made using IVDR.