First MDR Certificate Issued for Class III Device

Regulatory NewsRegulatory News | 20 September 2019 |  By 

Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system.

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, a spokesperson told Focus.

Biotronik said that it’s been working over the last two and half years to develop a plan to transition its devices and quality management system into the new EU legal framework for devices, which will be fully implemented in May 2020.

Last May, Germany-based TÜV SÜD became the second notified body to be designated under MDR. Two other notified bodies have since been designated, with the most recent coming in August.

“Since receiving designation and notification, TÜV SÜD has been working hard on shifting and preparing resources to provide services under the new legislative framework. We have had and continue to clarify open questions and implement newly published information about the MDR into our processes… The challenge now lies in balancing our existing MDD and AIMDD projects with the strong demand for MDR services in this transition period,” said Royth von Hahn, SVP and global head of medical & health services at TÜV SÜD Product Service.

The certification of Biotronik’s quality management system and Class III device follows an announcement from BSI’s UK notified body earlier this month that the Novartis Concept1 inhaler is the first device to be certified under MDR.


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