OpenLegislation

Division 7.1

United Kingdom

Original text. Later amendments are not shown.

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 deviceF1,

  • F2where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.

Annotations

Textual amendments

F1

Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).

F2

Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).