Council Directive 93/42/EECDangos y teitl llawn

1. General provisions U.K.

[F1 1.1. As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as ‘ clinical evaluation ’ , where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on: U.K.

1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where: U.K.

• there is demonstration of equivalence of the device to the device to which the data relates, and

• the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2. Or a critical evaluation of the results of all clinical investigations made. U.K.

1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.] 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).

[F2 1.1a In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data. U.K.

Textual Amendments

F2 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).

1.1b The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device. U.K.

1.1c The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented. U.K.

1.1d Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.] U.K.

1.2. All the data must remain confidential, in accordance with the provisions of Article 20. U.K.