In Vitro Diagnostic Medical Devices Directive

98/79/EC

The In Vitro Diagnostic (IVD) Medical Devices Directive is relevant to you if you design, manufacture or distribute IVD medical devices within the European Economic Area.

An in vitro diagnostic medical device is defined by the IVD Directive as "any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients".

Examples could include:

• HIV test kits
• blood gas analysers
• home use pregnancy tests
• blood collection tubes and specimen containers
• multi-analyte control sera
• immunoassay analysers and reagent kits
• blood glucose monitors for diabetics

Information on the directive and a copy of the directive text can be found on the European Commission website.

LRQA is designated as a notified body under the IVD directive for the full range of devices, under the following Annexes:

• Annex III - Design examination for self-test devices
• Annex IV - Full Quality Assurance
• Annex VII - Production Quality Assurance

LRQA is able to perform conformity assessment activities against the directive, such as:

• auditing a company's quality system
• conducting design dossier examinations for List A devices
• verifying that your technical documentation meets the requirements of the directive and is implemented within the system
• carrying out verification of manufactured batches of defined high risk IVDs
• conducting continued surveillance of the quality system.

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