ANNEX X U.K.CLINICAL EVALUATION

2. Clinical investigations U.K.

2.1. Objectives U.K.

The objectives of clinical investigation are:

• to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Annex I, and

• to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.

2.2. Ethical considerations U.K.

[F1 Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.] It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.

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).

2.3. Methods U.K.

2.3.1. Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims for the device; these investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions. U.K.

2.3.2. The procedures used to perform the investigations must be appropriate to the device under examination. U.K.

2.3.3. Clinical investigations must be performed in circumstances similar to the normal conditions of use of the device. U.K.

2.3.4. All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined. U.K.

[F1 2.3.5. All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.] U.K.

2.3.6. The investigations must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment. U.K.

The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device.

2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation. U.K.