# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4

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

The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.

---
Source: https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/I/division/4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-I/division-I/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.