S.L. 427.10 Art. 3Definitions.

For the purposes of these regulations, the following definitions shall apply:

"active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure; "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

"authorised representative" means any natural or legal person established in the Community or Malta who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community or Malta instead of the manufacturer with regard to the latter’s obligations under these regulations;

"CE marking" means marking as set out in Schedule IV; "clinical data" means the safety and, or performance information that is generated from the use of a device. Clinical data are sourced from:

(a) any clinical investigation of the device concerned; or

(b) any clinical investigation or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

(c) published and, or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated; "the Community" means the European Community; "custom-made device" means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices; "device intended for clinical investigation" means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in section 2(a) of Schedule VII in an adequate human clinical environment. For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner; "harmonised standard" means a technical specification adopted by the European Committee for Standardisation (CEN) or the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), upon a remit from the European Commission in accordance with the Notification Procedure Regulations;

"intended purpose" means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and, or in promotional material; "manufacturer" means the natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party:

(a) the obligations of these regulations to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and, or labels one or more ready-made products and, or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name;

(b) paragraph (a) does not apply to the person who, while not a manufacturer within the meaning of this definition, assembles or adapts devices already on the market to their intended purpose for an individual patient; "medical device" means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and, or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of -

(a) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(c) investigation, replacement or modification of the anatomy or of a physiological process,

(d) control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; "Medicines Authority" means the Authority as established under article 4 of the Medicines Act; "national standard transposing the harmonised standard" means a Standard issued by one of the members of CEN/CENELEC/ETSI which is declared and noted to be identical to the Harmonised Standard originally issued by CEN/CENELEC/ETSI;

"notified body" means a body notified to the Commission and to the Member States of the Community, assessed according to the criteria laid down in Schedule VIII and appointed to carry out the procedures referred to in regulation 11(1) to (7). The names of such bodies are published in the OJ;

"OJ" means the Official Journal of the European Union; "placing on the market" means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and, or use on the Community or Maltese market, regardless of whether it is new or fully refurbished; "putting into service" means making available to the medical profession for implantation;