Directive 98/79/EC of the European Parliament and of the CouncilDangos y teitl llawn

Article 4 U.K. Free movement

1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 16 if these devices have undergone conformity assessment in accordance with Article 9.

2. Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII.

3. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devicescannot be marketed or put into service until they have been made to comply.

4. Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user.

Provided that safe and correct use of the device is ensured, Member States may authorise the information referred to in the first subparagraph to be in one or more other official Community language(s).

In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:

(a) whether the information can be supplied by harmonised symbols or recognised codes or other measures;

(b) the type of user anticipated for the device.

5. Where the devices are subject to other directives concerning other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other directives.

However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, 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.