ANNEX 6 U.K. STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES

1. The manufacturer or his authorized representative established within the Community shall draw up for custom-made devices or for devices intended for clinical investigations the statement comprising the elements stipulated in section 2. U.K.

2. The statement shall comprise the following information: U.K.

2.1. For custom-made devices: U.K.

• [F1 the 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 [F1 duly qualified medical practitioner] who drew up the prescription and, if applicable, the name of the clinic concerned,

• [F1 the 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).

[F1 2.2. For devices intended for clinical investigations covered in Annex 7: U.K.

• 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.]

3. The manufacturer shall undertake to keep available for the competent national authorities: U.K.

3.1. [F1 For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.] U.K.

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.

3.2. For devices intended for clinical investigations, the documentation shall also contain: U.K.

• [F1 a 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,

• [F1 the 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,

• [F2 if 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.

[F2 4. The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product. U.K.

5. For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions: U.K.

(i)

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;

(ii)

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.]