Esaote obtains EC MDR certification for the new Magnifico

Esaote obtains EC MDR certification for the new Magnifico Open total-body magnetic resonance system.

The new European Union Medical Devices Regulation (MDR), Regulation (EU) 2017/745, came into force on May 26th, 2021.

Genoa, November 30th, 2021 – Esaote – a leading Italian company in the biomedical sector, in ultrasound, dedicated magnetic resonance imaging and information technology for healthcare – is pleased to announce that the new Magnifico Open total-body magnetic resonance system has obtained EC MDR certification.

The new certification attests to the Magnifico Open system’s compliance with the requirements of the new European Union Medical Devices Regulation (MDR), Regulation (EU) 2017/745, which entered into force on May 26th, 2021.

The new regulation, replacing Directive 93/42/EEC on medical devices (MDD) and others, was implemented by the European Parliament to improve the EU approval system for medical devices, by imposing strict requirements on both manufacturers and Notified Bodies involved in the conformity assessment of those devices.

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