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Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)
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- Revised 11/10/20070.15 MB
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- Revised 02/08/19930.22 MB
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[F17. Administrative provisions U.K.
7.1. On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant information on EC type-examination certificates and addenda issued, refused or withdrawn. U.K.
7.2. Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them. The annexes to the certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has been informed. U.K.
7.3. The manufacturer or his authorized representative shall keep with the technical documentation a copy of the EC type-examination certificates and the supplements to them for a period of at least [F215 years from the manufacture of the last product] .] U.K.Textual Amendments
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).
Textual Amendments
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).
F37.4.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
Textual Amendments
F3 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).
Textual Amendments
F1 Substituted by Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).
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