S.L. 427.10 Art. 5CE marking and conformity. S.L. 427.36

(1) The active implantable medical devices referred to in the definitions of "active implantable medical device", "custom-made device" and "device intended for clinical investigation", hereinafter referred to as "devices", shall satisfy the essential requirements set out in Schedule I which apply to them, account being taken of the intended purpose of the devices concerned.

(2) All necessary steps shall be taken to ensure that the 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, properly implanted and, or properly installed, maintained and used in accordance with their intended purposes.

(3) Where a relevant hazard exists, devices which also satisfy the definition of machinery in 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 1.

(4) Devices, other than those which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in regulation 5(1), must bear the CE marking of conformity.

(5) (a) The CE marking of conformity, as shown in Schedule IX, must appear in a visible, legible and indelible form on the sterile pack and, where appropriate, on the sales packaging, if any, and on the instruction leaflet.

(b) The CE marking must be followed by the identification number of the notified body responsible for implementation of the procedures set out in Schedules II, IV and V.

(6) It is prohibited to affix markings which are likely to deceive third parties as to the meaning and form of the CE marking. Any other marking may be affixed 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.

(7) 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 harmonised standards the reference of which have been published in the OJ.

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

(9) (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 OJ, 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.

(10) Obstacles shall not be created to the placing on the market or the putting into service within the Maltese territory of devices complying with the provisions of these regulations and bearing the CE marking provided for in sub-regulations (4) to (6), which indicates that they have been the subject of an assessment of their conformity in accordance with regulation 6(1) to (9).

(11) Obstacles shall not be created to:

(a) 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 regulation 7(1) to (4) and in Schedule VI;

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

Such devices shall not bear the CE marking.

(12) At trade fairs, exhibitions, demonstrations, etc., no obstacles 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 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.

(13) When a device is put into service, the information described in sections 14, 15, 16 and 17 of Schedule I is required to be in, at least, Maltese and, or English.