Arjo’s product range is now MDR and UKCA certified
Arjo has received its final Medical Device Regulation (MDR) and UKCA certificates for the EU and the United Kingdom respectively. Maintaining safe and high-quality products permeates all of Arjo’s development activities and remains constantly high on the Group’s agenda, with a clear connection to both customer value and business performance.
The completed certifications ensure that Arjo products can continue to be sold to European and UK customers with a valid CE or UKCA mark, and they include both ArjoHuntleigh and Huntleigh Healthcare products.
“These certificates are testaments to that we don’t cut corners when it comes to quality and compliance, and put us in a strong position in the industry as the certification process is rather long,” says Sara Harboe, VP Corporate QMS and Product Compliance. “The completed MDR certification also paves the way for access to other markets and tenders where this is a requirement.”
While Arjo’s recertification process is now finalized, many companies in the medical device industry still face major challenges in completing the recertification. Even if the MDR process was extended from its original deadline in 2024, all certificates issued under the Medical Device Directive (MDD) will expire in 2027-2028 – and manufactures are not allowed to make new or significant changes to products without an MDR certification. It is estimated that approximately 24,000 certificates under MDD will expire already in 2024.
“The recertification cases are being split between EU Notified Bodies with limited resources. Since still only a fraction of these Notified Bodies are accepting new customers, we are very happy to have this process behind us,” Sara concludes.
For more information, please contact:
Sara Harboe, VP Corporate QMS and Product Compliance
Tel: + +46 10 335 4756
Sara Ehinger, VP Investor Relations & Corporate Communications
Tel: +46 723 597 794
At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With more than 6,500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges. www.arjo.com