The current Medical Device Directive (MDD) covering the CE Mark for imaging devices was replaced last year by the Medical Devices Regulation (MDR), a more rigorous policy, Esaote said. All previous MDD CE certificates will expire in May 2024.
In 2022, Esaote said 25 of its ultrasound medical devices and two MRI devices have been certified under the new MDR CE Mark and that by the end of 2022, all of its ultrasound medical devices will have switched to production under the new MDR CE Mark.
Currently, about 23,000 certificates are covered in Europe by the MDD CE Mark, with only 4,100 so far certified under the new MDR CE Mark, Esaote added.
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