IVDD (In Vitro Diagnostic Directive) is the In Vitro Diagnostic Medical Devices Directive (EC-Directive 98/79 /EEC), which applies to blood cell counters, pregnancy detection devices, etc., and came into effect on June 7, 2000 , will be enforced on December 7, 2005. In vitro diagnostic devices refer to kits, calibration standards, instruments, tools, and systems that examine specimens collected from the human body outside the body to provide information required for medical treatment.
When Chinese medical device manufacturers and export companies sell their products to the EU market, they must comply with the above directives and affix the CE mark, otherwise it will be difficult for the products to enter the EU market.
Due to insufficient publicity in this regard, although AIMD in the above three directives has been mandatory for many years, and IVD was also mandatory in 1999, there are still many medical device manufacturers and export companies. These requirements are not well understood, so my country's medical device exports will face severe tests this year. Here we give a brief introduction to the IVDD directive and a more detailed explanation of the current application for CE certification for reference by relevant parties.