# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 7.1

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

The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the ‘General requirements’. Particular attention must be paid to:
the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,
the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device,
where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/II/division/7/division/7.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-7/division-7.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.