IRRAS Announces Notified Body Transition from GMED to DEKRA, a Global Leader in Inspection and Certifications
Stockholm, May 11, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the CE Mark certificates for its IRRAflow system and the company’s ISO13485:2016 certification have been transferred to a new notified body, DEKRA. After the successful completion of a recent audit by DEKRA, these CE Mark certificates for IRRAflow will remain valid until May 2024.
“With DEKRA, we are building a relationship with one of the largest, most respected notified bodies in the world,” said Will Martin, President and Chief Commercial Officer of IRRAS. “DEKRA has resources in place near our US headquarters in Southern California, so important regulatory work has continued despite Covid-19. We believe that this transition can shorten our approval timelines and allow us to consistently plan our European product introductions moving forward.”
“Consolidating our regulatory relationships with DEKRA, a global leader in the space, as our notified body is an important step in the long-term growth of IRRAS,” said Kleanthis G. Xanthopoulos, PhD., Chief Executive Officer of IRRAS. “Regulatory requirements have changed dramatically in Europe, and, as guidelines evolve, it is critical that we take needed steps to ensure that our life-saving products remain available to patients in Europe.”
Founded more than 95 years ago, DEKRA is the leading expert organization and largest notified body in Europe. DEKRA is one of the five largest notified bodies globally and was also one of the first notified bodies to be approved under Europe’s new Medical Device Regulations. The company currently employs more than 43,000 people in approximately 60 countries on six continents.
IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.
IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
Kleanthis G. Xanthopoulos, Ph.D.
+46 73 951 95 02
The information was released for public disclosure, through the agency of the contact person above, on May 11, 2021 at 08:30 (CET).