News about GMP/cGMP

25.09.2019

TÜV SÜD certifies first Class III medical device according to MDR

On 19 September, the notified body TÜV SÜD announced the certification of the first Class III medical device in accordance with the new EU Medical Devices Regulation (MDR).

Class III is the highest risk class for medical devices. They must meet particularly extensive requirements in terms of clinical safety and performance.
TÜV SÜD now certified the Renamic programming software device from the Berlin-based company Biotronik.
The device can be used to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy systems.
Biotronik announces that the company has been working for two and a half years on a transition plan to implement the new EU regulations.
Recently, the very first medical device was certified by the notified body of BSI UK (we reported).
TÜV SÜD has been the second notified body designated to certify medical devices according to MDR since May 2019.


Sources:

TÜV SÜD: Pressemitteilung   

Biotronik: Pressemitteilung  

RAPS: News



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