UL offers the most convenient and complete global regulatory access solution for in vitro diagnostic (IVD) device manufacturers.
We offer the option of integrating plans for product testing and integrated quality systems audits into one process, enabling our customers to efficiently satisfy regulatory requirements for multiple countries with one assessment.
UL conducts usability testing to assess the risk of use error.
Regulatory approvals are also contingent on validation of the quality system, and UL provides both certification and registration of quality systems to ISO 13485. We can also provide quality system gap assessment to ISO 9001 and ISO 13485.
UL supports regulatory approvals directly as a Notified Body under Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
Under the current EU IVD Directive (98/79/EC), UL has full competency and accreditation in IVD List A, List B and self-test devices. Our scope of accreditation aligns to meet the diverse and ever-changing needs of the IVD industry to include most self-test devices, including devices for urine analysis, endocrinology, general biochemistry and chemistry, general immunology, and diabetes diagnosis and management. The current IVD Directive will be replaced with new European regulations in late 2014 or early 2015. Regulatory oversight of IVD devices and manufacturers’ quality systems will increase substantially. A new risk-based classification system for devices will be introduced with four categories (A, B, C and D), with Class D being the highest-risk group. Only the very small group of Class A devices will be able to be self-certified by a manufacturer. Groups B to D will require a level of regulatory scrutiny proportional to patient risk. It has been proposed to designate special Notified Bodies to certify the highest-risk products, and UL is actively monitoring and reacting to the changing regulatory environment.
UL LLC., recognizes and respects the need to maintain impartiality through separation of its services. If an organization is certified with UL Medical & Regulatory Service to a management system, UL Medical solutions will not provide consultancy services for that particular management system and Notified Body for IVD and MDD.