Raising the bar for medical devices in Europe

CMR’s Chief Quality and Regulatory Officer, Chris Weatherall discusses the path to getting MDR certification for Versius

There is no doubt that the bar has been raised for medical devices to access the European market. And rightly so to support improved patient safety. While the process has become more challenging and complex for manufacturers, we are proud to have worked with BSI, to secure European Medical Devices Regulation 2017/745 (MDR) certification for Versius, our next-generation surgical robot. Medical devices, such as Versius can help hospitals and systems to deliver better surgical care and at CMR, we continue to uphold and deliver the highest standard in quality, demonstrated through our certification of Versius.

In 2019 when CMR Surgical launched Versius, we followed the IDEAL framework to bring the product to market responsibly conducting first-in-human clinical trials, securing CE mark, and introducing the system to a select number of hospitals across the UK. The system was launched alongside a clinical registry, one of the first in the world to collect data from the surgical procedures conducted using Versius that today is a core part of our comprehensive digital ecosystem. Why does that matter? Today we have over 100 systems used in hospitals all over Europe, as well as Latin America, India, the Middle East and Asia Pacific.

It is a significant investment for a company to go through the MDR process but there is a clear unmet need for surgical robotics and Europe is a region where we see significant growth, with only 1% penetration today. But we must all look at the long term and ensure medical devices are brought to market in a sustainable way. Having a more rigorous process builds trust amongst patients and hospitals that they are receiving the best technologies and for manufacturers, we have a duty to our customers to set the highest standards.

With health systems at capacity across Europe we have a significant opportunity for medical devices such as Versius to support health system’s recovery plans and deliver better surgical care and we should work together, along with regulators to make sure hospitals across Europe have access to the highest quality medical devices that can help to deliver better healthcare.

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