OpenLegislation

Division 1

United Kingdom

Original text. Later amendments are not shown.

For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representativeF1 established in the Community must draw up the statement containing the information stipulated in Section 2.

Annotations

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).