Services for In Vitro Diagnostic (IVD) devices

Integrated testing and auditing for IVDs

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.  This includes both certification and registration of quality systems to ISO 13485. And for those that are new to the process we can review your quality system and identify gaps to both ISO 9001 and ISO 13485.

In Vitro Diagnostic (IVD) Notified Body

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, UL can provide certification and approval for the EU market.  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 IVD regulations. Under the new IVDR, regulatory oversight of IVD devices and manufacturers’ quality systems will increase substantially.  It introduces a new risk-based classification system for devices 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, and will require a Notified Body.

UL is dedicated to supporting the IVD industry certification and testing needs.

As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.