Product

In Vitro Diagnostic Directive 98/79/EC

June 16, 2010

The purpose of the In Vitro Diagnostic Directive (98/79/EC), is to ensure that only safe and effective products are sold in the European market, with clearly outlined regulations regarding manufacturing, import and marketing. To declare compliance to the IVD directive, the CE Marking must be affixed to a manufacturer’s product.

The In Vitro Diagnostic Directive 98/79/EC was released and published on 7 December 1998 and has been in effect since 7 June 2000. With the end of the five-year transition period 7 December 2003, compliance to the IVD directive is mandatory. As a Notified Body for the In Vitro Diagnostic Directive 98/79/EC, TÜV Product Service is fully nominated for all IVD tests with no restrictions as outlined in the IVD directive.

It is important to note that beginning 7 December 2003 a two-year transition period applicable to inventory currently in the supply chain (placed on the market prior to 7 December 2003) took effect. Such product(s) can be “put into service” without compliance to IVDD 98/79/EC until 7 December 2005.

The IVD directive, similar to scope to the Medical Devices Directive, defines in article one, in vitro diagnostic devices 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 the providing information:

• Concerning a physiological or pathological state, or
• Concerning a congenital abnormality, or
• To determine the safety and compatibility with potential recipients, or
• To monitor therapeutic measures.”

If a product falls within the scope of the IVD directive, then it must fulfill the essential Requirements outlined in Annex I, taking into account the intended purpose of the devices concerned. Manufacturers of all classes of IVD’s are required to assemble technical documentation to demonstrate compliance with the Essential Requirements of the IVD directive.

A notified body, such as TÜV SÜD Product Service, is required for devices classified under Annex II list A, Annex II list B and products for self-testing. A notified body is not required for product or performance qualification and other IVD’s. It is recommended that manufacturers not requiring a notified body consult a TÜV SÜD Product Service IVD expert to ensure the IVD product is classified correctly and that the documentation is accurately compiled. Whether a notified body is required for your IVD product or not, TÜV SÜD Product Service has the expertise and experience to review your IVD product and its associated technical documentation and assist you in accessing the European marketplace.