OpenLegislation

Division 13.1 F1

United Kingdom

Original text. Later amendments are not shown.

Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.

This information comprises the details on the label and the data in the instructions for use.

As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices.

Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.

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).