The Zoll AED Plus defibrillator is now approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR, according to the company. This is the second Zoll defibrillator to receive the EU MDR certification after the Zoll AED 3 received approval in January 2024.
EU MDR is the European Union Medical Device Regulation 2017/745 that was adopted in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
The company now has CE marking for the Zoll AED Plus defibrillator under the EU MDR.
“Zoll is happy to have received our second MDR certification for our AED Plus,” said Elijah White, president of Acute Care Technology division. “With this new certification, customers will know that this device has passed the most stringent level of European medical regulation for a medical device.”
The company also reported it is continuing to pursue EU MDR approval for its Powerheart G5 and certification for its full portfolio of products.
