IVD Directive

IVDD stands for the In Vitro Diagnostic Medical Device Directive, one of three European directives on medical devices. The In Vitro Diagnostic Directive (Dir 98/79/EC) took effect in January 2004. This directive is a harmonized standard that will allow the sale of an IVD in the EU by affixing the CE Mark. The CE mark will notify all parties that the manufacturer has met all requirements of the IVDD as they pertain to the particular device. The Directive on in vitro diagnostic medical devices was officially adopted on October 27, 1998, and was published in the Official Journal of the European Communities on December 7, 1998.

The transition period for in vitro diagnostic medical devices expired on December 7, 2003. Today all in vitro diagnostic medical devices marketed in the EU must carry the CE Mark.

soventrans.com not only knows what IVDD is but also knows how important it is to your business. Please contact us if you need your product to be compliant with the IVD Directive.