IRRAS Receives Quality System Certification under MDSAP and Updated European Union Medical Device Regulation 2017 / 745

• IRRAS’ Quality Management System has been confirmed to comply with stringent standards required under both MDSAP and EU MDR programs, which also extends the company’s existing ISO 13485:2016 certification
• After completion of MDSAP audit, IRRAS can now pursue product regulatory clearance in its next wave of key markets, including Australia and Brazil
• Successfully completing the MDR quality audit is needed first step to qualify IRRAS’ products for CE Mark under new MDR requirements

Stockholm, June 8, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it has received certification of its Quality Management System (QMS) under the EU Medical Device Regulation (MDR) 2017/745 and the Medical Device Single Audit Program (MDSAP).  MDR and MDSAP are considered the highest audit standards in the medical device industry, and it is a substantial achievement to document IRRAS’ compliance. These added certifications serve as a significant validation of the company’s approach to delivering high-quality products to key countries around the globe.

MDSAP is a stringent audit process that was established to enable medical device manufacturers to undergo one single regulatory audit of their quality management system that covers the requirements of participating regulatory jurisdictions in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW) and the United States (FDA).  By successfully completing the MDSAP audit, IRRAS has demonstrated that it satisfies strict requirements related to the design, development, production, deployment, and sale of its solutions.  IRRAS now plans to use this MDSAP certification as the starting point to secure product regulatory clearance in these markets, starting with Brazil and Australia.

Also, by confirming that its QMS meets the new EU MDR guidelines, IRRAS can now move forward with seeking CE Mark for its IRRAflow and Hummingbird ICP Monitoring product lines under MDR.  As of May 26, 2021, all products that seek regulatory clearance in Europe must conform to the new EU Medical Device Regulation (MDR) 2017/745, which replaces the prior Medical Device Directive.  Successfully certifying its QMS to the more stringent MDR standards is an important step in completing the ongoing MDR CE Mark for Hummingbird.  The existing CE Mark for IRRAflow remains valid until May 2024, and this certification will help facilitate an extension under MDR at the appropriate time.

“At IRRAS, a commitment to quality underscores everything that we do,” said Kleanthis, G. Xanthopoulos, Ph.D., CEO of IRRAS.  “By certifying our QMS under both MDR and MDSAP, we have validated that commitment and confirmed our ability to maintain the highest quality standards within the medical device industry.”

"This achievement is the result of our team working closely with our new notified body, DEKRA, to successfully complete multiple audits across many months,” said Will Martin, IRRAS’ President and Chief Commercial Officer.  “Finalizing these important quality certifications is a significant early milestone in this partnership with DEKRA, and it also serves as an important building block for future revenue growth.  With these certificates in place, we can now ensure continued product availability in Europe, while also pursuing final regulatory clearance for our products in our next wave of targeted growth markets, such as Brazil and Australia.”

About IRRAS

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:

Sten Gustafsson
IR
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on June 8, 2021 at 10:00 (CET).