18.03.2024
Cerenion C-Trend® Software Library receives MDR Certificate
Cerenion C-Trend® Software Library is now certified as a CE-marked Class IIb medical device under the EU regulation on medical devices. “I’m extremely proud of our team for this significant achievement, which highlights our professionality and commitment to provide high quality products. Certification under MDR not only enables the long-term sales for C-Trend® in Europe, but also enables its continuous development to new application areas” says Jukka Kortelainen, CEO and co-founder of Cerenion. Also Sanna Hosio, the Quality and Regulatory Affairs Director of Cerenion, wants to recognize the people behind the achievement: ”This MDR certification process was a challenging yet very rewarding project and I like to thank our Cerenion team for excellent work as well as our Notified Body SGS Fimko for good co-operation.”
What is Medical Device Regulation, MDR
• The Regulation (EU) 2017/745 on Medical Devices (MDR) defines the requirements for placing medical devices on the market of in the EU. The regulation is in place since May 2021, and its intention is to unify the regulation in the EU and further improve patient safety.
• A Notified Body must assess the manufacturer’s quality management system to meet the requirements of MDR, unless the products falls into Class I (i.e. the risk level has been estimated as relatively low).
• The manufacturer is required to ensure that the product has been designed and manufactured in accordance with the MDR.
• Before the new regulation, medical devices were certified under Medical Device Directive (MDD). Any medical device on the market under the MDD certification will have to undergo a transition to MDR.
• A Notified Body must assess the manufacturer’s quality management system to meet the requirements of MDR, unless the products falls into Class I (i.e. the risk level has been estimated as relatively low).
• The manufacturer is required to ensure that the product has been designed and manufactured in accordance with the MDR.
• Before the new regulation, medical devices were certified under Medical Device Directive (MDD). Any medical device on the market under the MDD certification will have to undergo a transition to MDR.
What is Cerenion C-Trend® Software Library
C-Trend® Software Library transforms the complex raw EEG signal into a set of simple parameters that acute healthcare clinicians can read and act upon. It is currently available on Bittium’s BrainStatus EEG monitor in the EU under MDD since year 2021. C-Trend® software combines Cerenion’s own innovation, the C-Trend® Index, to other quantitative EEG derived parameters that yield information on an acutely ill patient’s brain function. Using the C-Trend® software, it is possible to monitor EEG slow wave activity, burst suppression ratio (BSR), aEEG and Alpha-Delta Ratio (ADR). These parameters may be used to detect brain ischemia and morphologies that are typical in epileptic seizures, as well as adjust the depth of sedation and evaluate the recovery after cardiac arrest. In addition to bedside view, the results of C-Trend® analysis can be viewed remotely by a consulting neurologist or clinical neurophysiologist.
Highlights
This website and all of the content therein is for reference purposes only and is not intended to substitute for advice from a licensed healthcare professional. Not available in the United States. Cerenion™, Cerenion C-Trend™, C-Trend™, "The next-generation brain monitoring company"™ and "The pulse of the brain"™ are registered trademarks and/or trademarks of Cerenion Oy. Cerenion C-Trend™ is intended for use by qualified medical practitioners who will exercise professional judgment in its use. Cerenion technology is protected by Intellectual Property Rights. Patents pending worldwide. All rights reserved. © Cerenion Oy 2020.