ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solution has announced that that the ZOLL AED 3® defibrillator has been approved under the European Union Medical Device Regulation 2017/745.
EU MDR is the European Union Medical Device Regulation 2017/745 released 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.
ZOLL has now obtained CE marking for the ZOLL AED 3 defibrillator under the EU MDR.
“ZOLL is very pleased to have received MDR certification for our ZOLL AED 3. This is the most stringent level of European medical regulation for a medical device and represents ZOLL’s long-standing commitment to product quality, safety, and efficacy.”Elijah White, President of ZOLL’s Resuscitation division.
ZOLL is continuing to work toward achieving EU MDR approval and certification for its full portfolio of products.