September 26, 2022
UL VS Limited has recently expanded its approved body scope to address the emerging needs of connected medical device manufacturers in the United Kingdom and Northern Europe.
The expanded scope of UL Solutions CB test laboratory in the U.K. includes IEC 60601-1 and IEC 61010-1 standards with their amendments and various collateral for laboratory equipment, in-vitro diagnostic (IVD) and medical electrical equipment.
Additional details on the medical device and IVD standards and CB scheme
IEC 60601-1 and IEC 61010-1 are internationally harmonized safety standards for electromedical equipment and for laboratory and test and measurement equipment. To receive approval in global markets, manufacturers of higher-risk medical devices and diagnostic laboratory equipment must demonstrate their safety and effectiveness through the submission of test data. Many regulators around the world recognize the IEC 60601-1 and IEC 61010-1 series of standards as a means of demonstrating device safety. The IECEE established the CB Scheme, an international network made up of product certification organizations in more than 50 countries around the world, to provide a means for the mutual acceptance of CB Test Certificates and CB Test Reports for the purpose of obtaining national certification or markings.
Benefits to UL Solutions customers
UL Solutions expanded scope helps ensure UL Solutions continues to provide a pathway to international compliance through strengthened local capabilities for customers in the U.K. and Northern Europe. Medical device, laboratory equipment and IVD manufacturers in the region can now take full advantage of UL Solutions local testing to support global regulatory approvals directly through the U.K. office.
Our experts are experienced industry professionals who can help our customers through the complexities of medical device approvals. We provide global compliance expertise with the convenience of regional service through local teams.
Contact us to learn how we can help you achieve your compliance goals for medical and in-vitro diagnostic products.