OpenLegislation

Division 2.1

United Kingdom

Original text. Later amendments are not shown.

for custom-made devices:

  • F1the 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,

  • F2the 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;

Annotations

Textual amendments

F1

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).

F2

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).