BIOTRONIK Obtains the World’s First MDR Certification for a Class III (Highest Risk) Medical Device
The First Class III Medical Device is Certified Under the New European Medical Device Regulation
BIOTRONIK today announced that it is the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, BIOTRONIK also obtained MDR certification for its quality management system.
The MDR was introduced by the European Union (EU) with the aim to establish a modernized and more robust EU legislative framework to ensure better protection of public health and patient safety. The regulation will be fully applicable by May 2020. Over the past two and a half years, BIOTRONIK has developed a comprehensive company-wide project to manage the timely transition of all its medical devices as well as its quality management system into the new legal framework.
“The MDR brings a complete change to the regulatory framework for medical devices in Europe that emphasizes quality and safety,” said Roman Borkowski, Senior Vice President Quality Management and Regulatory Affairs, Cardiac Rhythm Management at BIOTRONIK. “As a global leader in cardio- and endovascular medical technology, BIOTRONIK has a long history of commitment to quality and safety. That’s why we are very proud to be the first company to demonstrate conformity to the highest MDR risk classification.”
Class III medical devices represent the highest risk class of medical devices according to the MDR. Therefore, these devices are required to meet extensive clinical safety and performance requirements and undergo the highest level of device approval.
Obtaining the first MDR certificate for a Class III medical device is just the first in a series of vital steps towards MDR certification of BIOTRONIK’s entire product portfolio. Mr. Borkowski commented: “With our first MDR milestone, we are pleased to have set a precedent for the future.”
At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.