The ZOLL AED 3 defibrillators comply with the strict requirements of the Medical Device Regulation (MDR). ZOLL is thus one of the first manufacturers to obtain CE certification under the MDR.

View the ZOLL AED 3 semi-automatic or vending machine.

ZOLL is also actively working on obtaining EU MDR approval for the ZOLL AED Plus, Powerheart G5 AED, and ZOLL electrodes.

What is the MDR?
The MDR (Medical Device Regulation) sets new, stricter requirements for medical devices sold in Europe. This law has been in force since 26 May 2021. Manufacturers have until 26 May 2024 to apply for a reassessment under the MDR for each medical device. To do so, they must update their quality management system and technical documentation, among other things.

After control, an ‘extended MDD certificate’ is first issued. This allows the manufacturer to continue selling the device in question after May 26, 2024. The MDD certificate is valid until the official MDR certification is issued.

Learn more about the MDR