Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (c. 42)

ANNEX VIII U.K. STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES

1. For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative[F1 established in the Community] must draw up the statement containing the information stipulated in Section 2. U.K.

Textual Amendments

F1 Deleted 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. The statement must contain the following information: U.K.

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

• [F2 the name and address of the manufacturer,]

• data allowing identification of the device in question,

• a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient,

• the name of the medical practitioner or other authorized person who made out the prescription and, where applicable, the name of the clinic concerned,

• [F3 the specific characteristics of the product as indicated by the prescription,]

• a statement that the device in question conforms to the essential requirements set out in Annex I and, where applicable, indicating which essential requirements have not been fully met, together with the grounds;

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).

F3 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).

2.2. for devices intended for the clinical investigations covered by Annex X: U.K.

• data allowing identification of the device in question,

• [F3 the clinical investigation plan,]

• [F2 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 7.4 of Annex I,

• a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,]

• the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

• the name of the medical practitioner or other authorized person and of the institution responsible for the investigations,

• the place, starting date and scheduled duration for the investigations,

• a statement that the device in question conforms to the essential requirements apart from the aspects covered by 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 must also undertake to keep available for the competent national authorities: U.K.

[F3 3.1. For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.] U.K.

The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph;

[F3 3.2. For devices intended for clinical investigations, the documentation must contain: U.K.

• a general description of the product and its intended use,

• design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

• the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation 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 this Directive if the standards referred to in Article 5 have not been applied,

• if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, 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,

• if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,

• the results of the design calculations, and of the inspections and technical tests carried out, etc.

The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.

The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.]

[F3 4. The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.] U.K.

[F2 5. For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, 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 subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.]