OpenLegislation

Division 4.3 Rule 15

United Kingdom

Original text. Later amendments are not shown.

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specifically to be used for disinfecting medical devices are in Class IIa. F1Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.

This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.

Annotations

Textual amendments

F1

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).