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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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Changes over time for: Article 4

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Article 4U.K.+E.U.

[F11. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.

2. Member States shall not create any obstacles to:

  • devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,

  • custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.

These devices shall not bear the CE marking.

3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.]

4.When a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex 1 to be in their national language(s).

(a)

Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices are also presumed to conform to the provisions of the other Directives.

(b)

However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity to the provisions only of those Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities , must be given in the documents, notices or instructions required by the Directives and accompanying such devices; these documents, notices or instructions shall be accessible without it being necessary to destroy the packaging which keeps the device sterile.]

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