Directive 98/79/EC of the European Parliament and of the CouncilDangos y teitl llawn

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

2.The manufacturer must prepare the technical documentation described in section 3 and ensure that the manufacturing process follows the principles of quality assurance as set out in section 4.U.K.