EBA concerned with rules on medical devices and in vitro diagnostics

The European Blood Alliance responded to the European Commission’s target evaluation of Regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostics. These Regulations aim to ensure the availability of safe and effective devices to protect patient safety and public health.

EBA welcomed the MDR and IVDR and their decisive contribution to a more harmonised framework across Europe. The implementation of the current MDR and IVDR, however, raised many challenges and had unintended consequences which impact blood establishments today and are expected to continue doing so in the future.

The targeted evaluation will help the Commission assess whether the rules are effective, efficient and proportionate, and whether they meet current and emerging needs.

You can download the full EBA submission or read it here.