Esaote has obtained European Commission (EC) Medical Devices Regulation (MDR) certification for its new Magnifico Open total-body MR machine.
The new European Union (EU) Regulation 2017/745 went into effect in May and replaces Directive 93/42/EEC on medical devices to improve the EU approval system for medical devices. It imposes strict requirements on both manufacturers and notified bodies involved in the conformity assessment of those devices.
The MDR certification for the Esaote Magnifico Open was issued by the TüV SüD certification body and the evaluation criteria included more precise and rigorous requirements in terms of the content and scope of the technical documentation required.
Esaote's open MR system with an easy-to-access patient table has a permanent magnet that is easy to use and lowers operating costs, the firm said.
