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[F1the name and address of the manufacturer,
the information necessary for the identification of the product in question,]
a statement affirming that the device is intended for exclusive use by a particular patient, together with his name,
the name of the [F1duly qualified medical practitioner] who drew up the prescription and, if applicable, the name of the clinic concerned,
[F1the specific characteristics of the product revealed by the prescription,]
a statement affirming that the device complies with the essential requirements given in Annex 1 and, where applicable, indicating which essential requirements have not been wholly met, together with the grounds.
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).
data allowing the devices in question to be identified,
the clinical investigation plan,
the investigator's brochure,
the confirmation of insurance of subjects,
the documents used to obtain informed consent,
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
the place, date of commencement and duration scheduled for the investigations,
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.]
The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in the first paragraph.
[F1a general description of the product and its intended use,]
design drawings, manufacturing methods, in particular as regards sterilization, and diagrams of parts, sub-assemblies, circuits, etc.,
the descriptions and explanations necessary for the understanding of the said drawings and diagrams and of the operation of the product,
[F1the results of the risk analysis and a list of the standards] laid down in Article 5, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements of the Directive where the standards in Article 5 have not been applied,
[F2if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,]
the results of the design calculations, checks and technical tests carried out, etc.
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).
The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in 3.1 and in the first paragraph of this section.
The manufacturer may authorize the evaluation, by audit where necessary, of the effectiveness of these measures.
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 or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.]
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