ZOLL and the Medical Device Regulation (MDR)

New regulations by the European Union to ensure and increase patient safety

Part of our mission at ZOLL® is developing and marketing meaningful products and technologies that deliver superior clinical performance. These products help healthcare professionals, emergency responders, and lay rescuers save lives every day.

ZOLL's focus on innovative, clinically superior technology for resuscitation and acute critical care as well as rigorous adherence to regulatory compliance programs is very much in alignment with the new European regulations for medical devices. The Medical Device Regulation (MDR) aims to ensure better protection of public health and patient safety and to establish a modernised and more robust EU legislative framework.

Our experienced regulatory team has put the necessary project teams in place to ensure a prompt transition of our products' CE marking from MDD to MDR. ZOLL has a proven record of successful product certifications and registrations around the world. In 2018, ZOLL was the first company to receive premarket approval from the FDA in the U.S. on its full portfolio of defibrillators. With our experience in manufacturing safe medical devices for 40 years, we are prepared to meet the extended requirements of MDR (e.g., clinical evidence, device identification, quality management and post-market surveillance).