OpenLegislation

Division 4.1 Rule 13

United Kingdom

Original text. Later amendments are not shown.

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive F12001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.

All devices incorporating, as an integral part, a human blood derivative are in Class III.

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).