ANNEX IX U.K.CLASSIFICATION CRITERIA

II. IMPLEMENTING RULES U.K.

2. Implementing rules U.K.

2.1. Application of the classification rules shall be governed by the intended purpose of the devices. U.K.

2.2. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used. U.K.

2.3. Software, which drives a device or influences the use of a device, falls automatically in the same class. U.K.

2.4. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. U.K.

2.5. If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the higher classification shall apply. U.K.

[F1 2.6. In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means ‘ an uninterrupted actual use of the device for the intended purpose ’ . However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.] U.K.

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).