Ability Drive® is CE marked according to the MDR requirements.
Ability Drive® meet all, of the relevant requirements of the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, with amendments (MDR).
The regulation helps to ensure patient safety, which among other thing means that the medical device works as intended, is continuously evaluated and documented, and that the benefits of using it outweigh any risks. It also implies that the safety and performance of the equipment is monitored after the equipment has been placed on the market.
