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TRaC Offers Safety Test Service for In Vitro Diagnostic Medical Systems
TRaC, the leading test house, now has full accreditation at its UK facilities to carry out safety testing of all medical diagnostic products that fall within the scope of the In Vitro Diagnostic (IVD) Medical Devices Directive.
In Vitro Devices are items of diagnostic equipment that carry out medical tests on samples (for example, blood) obtained from the human body, but that do not operate directly in contact with the body. The IVD Directive lays down a specific set of requirements for such equipment (distinct from diagnostic equipment such as monitors that are connected to the patient and have their own regulatory framework) in terms of their safety, quality and performance.
The IVD Directive sets out four classifications of product: General; Self-Test (i.e. products that patients may use themselves without medical supervision); and two higher categories of Test Kits and Devices that