Directive 98/79/EC of the European Parliament and of the CouncilShow full title

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

5.2.The notified body must affix, or have affixed, its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.U.K.