S.L. 427.44 Art. 3Definitions.

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

"accessory" means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device; "animal tissues" covered by these regulations are those tissues originating from bovine, ovine and caprine animal species, as well as deer, elk, mink and cats; "authorised representative" means any natural or legal person established in the Community or in Malta who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community or in Malta instead of the manufacturer with regard to the latter’s obligations under these regulations;

"cell" means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment; "CE marking" means marking as set out in Schedule XII;

"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 study 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(c) published and, or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;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. The prescription may also be made out by any other person authorised by virtue of his professional qualifications to do so. 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; "derivative" means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;

"device intended for clinical investigation" means any device intended for use by a duly qualified medical practitioner when conducting investigations, as referred to in Schedule X, 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;

"device subcategory" means a set of devices having common areas of intended use or common technology;

"generic device group" means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; "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;

"inactivation" means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;

"in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

(a) concerning a physiological or pathological state, or

(b) concerning a congenital abnormality, or

(c) to determine the safety and compatibility with potential recipients, or

(d) to monitor therapeutic measures; "specimen receptacles" are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of diagnostic examination. For in vitro the purposes of these regulations, specimen receptacles are considered to be in vitro diagnostic medical devices. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

"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 materials; "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) provided that 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) provided further that the first proviso to this definition 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, 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; "medical device manufactured utilising tissues of animal origin" means medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue. This definition does not apply to medical devices manufactured utilising tissues of animal origin which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only; "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; "non-viable" means having no potential for metabolism or multiplication; "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 XI and appointed to carry out the procedures referred to in regulations 6(1) to (12). 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 the stage at which a device has been made available to the final user as being ready for use on the Community or local market for the first time for its intended purpose; "reduction, elimination or removal" means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;

"single use device" means a device intended to be used once only for a single patient;

"source country" means the country in which the animal was born, has been reared and, or has been slaughtered;

"starting materials" means raw materials or any other product of animal origin out of which, or with the help of which, devices referred to in the definition for "medical devices manufactured utilizing tissues of animal origin" are produced; "tissue" means an organisation of cells and, or extra-cellular constituents; "transmissible agents" means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalopathies agents and scrapie agents;

"TSE certificate" means the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines.