EU MDR certifies ClearPoint Neuro manual SmartTwist Hand Drill and MR Drill Kit

ClearPoint Neuro, announced receipt of European Medical Device Regulation or EU MDR. clearance for the manual SmartTwist MR Hand Drill and SmartTip MR Drill Kit. Additionally, the Company received updated certification from its Notified Body allowing for shipment of products manufactured at its new Carlsbad, California facility to Europe. European Medical Device Regulation 2017/745 EU MDR , the new medical device regulation applicable in Europe, replaces the previous Medical Device Directive 93/42/EEC regulation. With the introduction of EU MDR, the EU is placing greater emphasis on safety measures, risk management, post-market surveillance, and data collection of medical devices for companies who wish to obtain European market access.”EU MDR is much more rigorous than MDD, forcing many medical device companies in our space who wish to enter or continue commercialization in Europe to closely assess every product before committing the time and resources necessary to meet its requirements,” stated Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. “Our team has risen to this challenge, especially given the importance of the EU to our pharmaceutical partners.”