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

ANNEX III U.K. EC DECLARATION OF CONFORMITY

4. The manufacturer shall take necessary measures to ensure that the manufacturing process follows the principles of quality assurance as appropriate for the products manufactured. U.K.

The system shall address:

• the organisational structure and responsibilities,

• the manufacturing processes and systematic quality control of production,

• the means to monitor the performance of the quality system.