Ce Marking Certification Service

Service Details:

Medical device certification CE Marking - MDD Directive

Medical Devices classified under the MDD must be registered with a Competent Authority before they can be sold in the EU bearing the Requisite CE Mark. As a Notified Body under the Competent Authority of the UK, UL's scope under the MDD includes class I sterile, class I measuring, class IIa, class IIb and I class III Active Medical Devices.

Medical device certification CE Marking – IVD Directive

UL has experienced staff with over 100 years of combined experience in In Vitro Diagnostic Devices. 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