ClearPoint Neuro, Inc. announced the receipt of European Medical Device Regulation (EU MDR) approval for its SmartFlow Neuro Cannula. This certification is a crucial regulatory achievement for the company's product portfolio.
The SmartFlow Cannula had previously been cleared under the Medical Device Directive 93/42/EEC (MDD). The successful attainment of the more rigorous EU MDR certification was completed well ahead of the 2027 deadline for Class III devices.
This approval ensures that ClearPoint Neuro's SmartFlow Cannula remains compliant with the latest European medical device regulations, facilitating its continued availability and use in the European market for precise neuro-delivery applications.
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