ANNEX 1 U.K.ESSENTIAL REQUIREMENTS

I. GENERAL REQUIREMENTS U.K.

1. The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons. U.K.

2. The devices must achieve the performances intended by the manufacturer, viz. be designed and manufactured in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a) as specified by him. U.K.

3. The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use. U.K.

4. The devices must be designed, manufactured and packed in such a way that their characteristics and performances are not adversely affected in the storage and transport conditions laid down by the manufacturer (temperature, humidity, etc.). U.K.

5. Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended. U.K.

[F1 5a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.] 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).