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).
[F1a general description of the product, including any variants planned and its intended use(s),]
design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.,
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operations of the product,
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,
[F1in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,]
the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,
[F1the solutions adopted as referred to in Annex I, Chapter I, Section 2,
the pre-clinical evaluation,]
[F2the clinical evaluation in accordance with Annex X,]
the label and instructions for use.
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).
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.
in the case of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions,
in the case of devices with a measuring function, only the aspects of manufacture concerned with the conformity of the products with the metrological requirements.
Section 6.1. of this Annex is applicable.
In line with Article 11 (2), this Annex may apply to products in Class IIa, subject to the following derogation: