S.L. 427.44 Art. 5S.L. 427.36

(1) The devices must meet the essential requirements set out in Schedule I which apply to them, taking account of the intended purpose of the devices concerned.

(2) All necessary steps shall be taken to ensure that devices may be placed on the market and, or put into service only if they comply with the requirements laid down in these regulations when duly supplied and properly installed, maintained and used in accordance with their intended purpose:

(a) Where a relevant hazard exists, devices which are also machinery within the meaning of regulation 3.1.1 of the Machinery Regulations, shall also meet the essential health and safety requirements set out in Schedule I to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Schedule I.

(b) All necessary steps shall be taken to ensure that devices referred to in the definition for "medical device manufactured utilising tissues of animal origin" in article 3 are placed on the market and put into service only if they comply with the provisions of these regulations and with the specifications laid down in Schedule XIII.

(3) Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in sub-regulation (1) must bear the CE marking of conformity when they are placed on the market.

(4) The CE marking of conformity, as shown in Schedule XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Schedules II, IV, V and VI.

(5) It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed on the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.

(6) (a) Compliance with the essential requirements referred to in sub-regulation (1) shall be presumed in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the OJ.

(b) For the purposes of these regulations, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the OJ.

(7) 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 also fulfil the provisions of the other Directives:

Provided that 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 OJ, must be given in the documents, notices or instructions required by the Directives and accompanying such devices.

(8) No obstacle shall be created to the placing on the market or the putting into service of devices bearing the CE marking provided for in sub-regulations (3) to (5) which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of regulation 6(1) to (12).

(9) No obstacle shall be created to:

(a) devices intended for clinical investigation being made available to medical practitioners or authorised persons for that purpose if they meet the conditions laid down in regulation 9(1) to (8) and in Schedule VIII; and

(b) custom-made devices being placed on the market and put into service if they meet the conditions laid down in regulation 6(1) to (12) in combination with Schedule VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Schedule VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.

Such devices shall not bear the CE marking.

(10) At trade fairs, exhibitions and demonstrations, no obstacle shall be created to the showing of devices which do not conform to these regulations, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.

(11) When a device reaches the final user, regardless of whether it is for professional or other use, the information which must be made available to the user and the patient in accordance with section 13 of Schedule I, shall be provided in, at least, the Maltese or English language.