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ColdZyme® certified under the new EU medical device regulation (MDR) | ||||
By: PR Newswire Association LLC. - 11 Mar 2024 | Back to overview list |
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LUND, Sweden, March 11, 2024 /PRNewswire/ -- Enzymatica's mouth spray ColdZyme® has received CE-certification under the new and more demanding European Union medical device regulation (MDR). This important milestone validates the company's scientific data and extends product claims throughout the EU. The certification is a key pillar for expansion in several markets and is expected to have long-term positive effects on Enzymatica's growth. Eurofins, a European approved notified body for medical devices, has certified the ColdZyme® product line MDR (class III) according to the European Union medical device regulation. MDR replaces the previous EU regulation MDD and imposes stricter requirements on evidence of clinical validity, safety design, and market surveillance. ColdZyme is one of the first flu- and cold products to be certified under the new regulation. "This is an important milestone in the history of Enzymatica as the MDR certification validates our scientific data and creates great commercial opportunities for us. In addition, it increases the consumer confidence in ColdZyme® as well as opens up new markets. The certification is highly anticipated by our partners since it ensures long term security which will contribute to Enzymatica's growth," says Claus Egstrand, CEO of Enzymatica. Eurofins has reviewed full data including safety, efficacy, and product claims. ColdZyme® has maintained the highest MDR classification, class III, during the process and both intended use and product claims are now able to expand due to the MDR-certification. "This certification process has meant extensive review of our quality processes and product data in accordance with the medical device legislation. Our expanded, verified health claims will now help us to communicate ColdZyme's benefits and efficacy even more clearly towards customers, retailers, and partners," says Ann-Christine Provoost, Director Regulatory Affairs. ColdZyme® MDR certification ColdZyme® provide an effective barrier that protects the oral cavity and throat and creates an osmotically active transient barrier that traps viruses deactivates and inhibits the viruses' ability to bond, deactivating their ability to infect cells. ColdZyme® products are now MDR certified with the following expanded intended use:
and with the following expanded product claims:
For more information, please visit https://coldzyme.co.uk/ About MDR The Medical Device Regulation (MDR) is an EU regulation to ensure the safety and performance of medical devices.
For more information, please contact: Claus Egstrand, CEO, Enzymatica AB Stefan Olsson, Communication Manager, Enzymatica AB References: 1. Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 About Enzymatica This information was brought to you by Cision http://news.cision.com The following files are available for download:
View original content:https://www.prnewswire.co.uk/news-releases/coldzyme-certified-under-the-new-eu-medical-device-regulation-mdr-302085228.html |
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