OpenLegislation

Division 2.3.6

United Kingdom

Original text. Later amendments are not shown.

The investigations shall be performed under the responsibility of an F1duly qualified medical practitioner or authorised person, in an appropriate environment.

The medical specialist shall have access to the technical data regarding the device.

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).