Microbot Medical Inc. has announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body.
The Notified Body will audit the Company to verify the compliance of its quality management system and the quality of the LIBERTY Robotic Surgical System development with widely acceptable standards in the medical device industry. In addition, preparations are being made to obtain EU-MDR certification (European Medical Devices Regulation) leading to CE mark, which would allow the Company to sell the LIBERTY Robotic Surgical System throughout the European Union.
“Following the success of multiple pre-clinical studies conducted with the participation of leading European-based interventional radiologists, Microbot is now expanding to seek a wider range of potential users in key growth markets,” commented Harel Gadot, Chairman, President and CEO. “We believe the LIBERTY Robotic Surgical System has the potential to revolutionize the way catheterization is being done today, by providing a single-use system designed to provide a high degree of stability, as demonstrated in our pre-clinical studies.”
Source: Microbot Medical