itro 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 test for specified conditions. As with any electrical product offered for sale in Europe, the supplier within the EU must affix the CE Mark; specified test regimes range from Self-Declaration of Conformance by the manufacturer (which is permitted for the General product category); through to a Declaration endorsed via an audit by a Notified Body; to a full third-party test programme carried out on production samples of a product.
TRaC is authorised and equipped to review design dossiers that manufacturers prepare, and to carry out type-testing where appropriate, in respect of the Safety requirements of the Directive. TRaC is accredited by UKAS (United Kingdom Accreditation Service) for EN 61010-2-101, the standard that governs safety in laboratory equipment, and especially (IVD) medical equipment. This qualification increases TRaC’s support of Medical Device manufacturers by adding the endorsement of a widely-recognised test house to the CE Marking of their products, and by speeding their time-to-market through comprehensive knowledge of the IVD Directive’s regulations and processes.
As with the many other Standards and Directives for which the test house holds qualifications, TRaC’s involvement with a client’s product design cycle can begin long before the audit or test programme is due, ensuring that all requirements are met during the design process and avoiding any delays as the product comes to market.
TRaC provides accredited approval services for other legislative requirements applicable to these products and through close coordination can manage complete qualification and approval programmes.