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. 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.
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.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.