ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification
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ZOLL® is proud to announce that the ZOLL AED 3® defibrillators are in compliance with the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR.
What does this mean?
The EU MDR adds new requirements for medical devices marketed in Europe. During the transition periods, manufacturers are expected to update their quality management system and technical documentation to meet MDR requirements prior to achieving MDR certification.
ZOLL has obtained CE marking for these defibrillators under the EU MDR and the new certification.
What about the ZOLL AED Plus and Powerheart G5 AEDs?
At this time, ZOLL continues to work diligently toward achieving EU MDR approval and certification for the ZOLL AED Plus® and Powerheart® G5 automated external defibrillator and ZOLL electrodes.
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