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Division 1.1.1 Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:F1

United Kingdom

Original text. Later amendments are not shown.

  • there is demonstration of equivalence of the device to the device to which the data relates and,

  • the data adequately demonstrate compliance with the relevant essential requirements.

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).