# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 5.2

Extent: E+W+S+N.I.

The manufacturer must authorize the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular:
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, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, 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.

---
Source: https://www.legislation.gov.uk/eudr/1993/42/annex/II/division/5/division/5.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-II/division-5/division-5.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.