Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (c. 385)

ANNEX 7 U.K. CLINICAL EVALUATION

2. Clinical investigation U.K.

2.1. Purpose U.K.

The purpose of clinical investigation is to:

• verify that, under normal conditions of use, the performances of the device comply with those indicated in section 2 of Annex 1,

• determine any undesirable side effects, under normal conditions of use, and assess whether they are acceptable risks having regard to the intended performance of the device.

2.2. Ethical consideration U.K.

Clinical investigations shall be made in accordance with the Declaration of Helsinki approved by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and amended by the 29th World Medical Assembly in Tokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice, Italy, in 1983. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Declaration of Helsinki. This includes every step in the clinical investigation from first consideration of need and justification of the study to publication of results.

2.3. Methods U.K.

2.3.1. Clinical investigations shall be performed according to an appropriate state of the art plan of investigation defined in such a way as to confirm or refute the manufacturer's claims for the device; the investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. U.K.

2.3.2. The procedures utilized to perform the investigations shall be appropriate to the device under examination. U.K.

2.3.3. Clinical investigations shall be performed in circumstances equivalent to those which would be found in normal conditions of use of the device. U.K.

2.3.4. All appropriate features, including those involving the safety and performances of the device, and its effects on the patients, shall 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.

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).

2.3.6. The investigations shall be performed under the responsibility of an [F1 duly qualified medical practitioner or authorised person], in an appropriate environment. U.K.

The medical specialist shall have access to the technical data regarding the device.

2.3.7. The written report, signed by the responsible medical specialist, shall comprise a critical evaluation of all the data collected during the clinical investigation. U.K.