Which products will be CE-marked, which products not?
"In-vitro-diagnostica" are defined by the legislator to be medical products which, in accordance to the particular purpose determined by the producer of the goods, are used for the in-vitro-determination of specimens from the human body including blood and human tissue donations.
General laboratory products are not considered as in-vitro diagnostica unless, due to their characteristics and in accordance to the particular purpose determined by the producer, they have to be used especially for in-vitro determinations.
In-vitro diagnostica which formerly had to be supplied "officially tested and stamped" within the Federal Republic of Germany will be supplied with CE-mark in the European Union. Capillary tubes for blood specimens, blood diluting pipettes and blood sedimentation pipettes will also be supplied with CE-mark within the European Union.