THE IN-VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE
The purpose of the In-Vitro Diagnostic Directive (IVD) is to ensure that only safe and functional products are sold in the European market, with clearly outlined regulations regarding manufacturing, import and marketing.
The purpose of the In-Vitro Diagnostic Directive is to ensure that only safe and functional products are sold in the European market, with clearly outlined regulations regarding manufacturing, import and marketing. The Directive was published on December 7th 1998, and has been in effect since June 7th 2000.
Compliance to the Directive will be obligatory from December 6th 2003. This is decisive in the harmonisation of regulations for medical devices in Europe.
Prior to the IVD Directive some countries individually regulated manufacturing and surveillance of in vitro diagnostic products while others did not regulate at all. The IVD Directive has now created the fundamental basis to ensure that the quality of such high risk products is tested and confirmed by neutral third party Notified Bodies.
