|Services||- Medical Services|
TÜV SÜD Product Service is a Notified Body for the European Union In Vitro Diagnostic Directive IVDD 98/79/EC, offering clients certification services to the full scope of the directive.
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 IVDD, the CE Marking must be affixed to a manufacturer's product.
It is important to note that beginning December 7, 2003 a two-year transition period applicable to inventory currently in the supply chain (placed on the market prior to December 7, 2003) took effect. Such product(s) can be "put into service" without compliance to IVDD 98/79/EC until December 7, 2005.
The IVDD, 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:
If a product falls within the scope of the IVDD, 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 IVDs are required to assemble technical documentation to demonstrate compliance with the Essential Requirements of the IVDD.
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 IVDs. 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.
For a comparison of the In Vitro Diagnostic Directive 98/79/ec and Medical Devices Directive, click here.
For more information, contact us.