OpenLegislation

Division 2.1

United Kingdom

Original text. Later amendments are not shown.

For custom-made devices:

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

  • 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.

Annotations

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).