Biotronik said today that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device.
The newly certified device is Biotronik’s Renamic programmer software, which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy systems, according to the Berlin, Germany-based company. Following a conformity assessment, Biotronik also obtained MDR certification for its quality management system.
The European Commission is upgrading its regulatory framework for medical devices with the MDR and for in-vitro diagnostics with the IVDR. The regulation will be fully applicable by May 2020. In addition to complying with the new regulation for new technology, medtech companies that have devices already approved in the EU must decide whether to seek MDR certification for them. Biotronik said it 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, SVP of quality management and regulatory affairs for cardiac rhythm management at Biotronik, in a news release. “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.”
Obtaining the first MDR certificate for a Class III medical device is the first in a series of steps toward MDR certification of Biotronik’s entire product portfolio, according to the company.
“With our first MDR milestone, we are pleased to have set a precedent for the future,” Borkowski said.