ZOLL AED 3 and AED Plus defibrillators are now MDR compliant

ZOLL^® is proud to announce that the ZOLL AED Plus^® defibrillator is now in compliance with the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR. The ZOLL AED 3^® defibrillator was approved under MDR on 02 February 2024.

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 other devices and products offered by ZOLL Medical?

ZOLL’s portfolio of electrodes is also MDR compliant. At this time, ZOLL continues to work diligently toward achieving EU MDR approval and certification for our other AED — Powerheart^® G5 automated external defibrillator — as well as our ALS portfolio.

As the manufacturer, we confirm all our devices are in compliance with the conditions listed in Article 120.3c of the Medical Device Regulation for continued placement on the market until 2027 or 2028, according to their respective risk class. For further information, please contact your local ZOLL representative or send an email to: [email protected].