# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1.1b

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

The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

---
Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/1/division/1.1b (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-1/division-1.1b
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.