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 manufacturer must authorise the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular:U.K.

  • the documentation on the quality system,

  • the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation, tests, etc.,

  • the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.