Our glossary for guidance - Category MDD

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.

'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.

[Definition according to (93/42/EEC) Article 1 No. 2b]

Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

[Definition according to (93/42/EEC) Annex IX No. 1.6]

Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices.

[Definition according to (93/42/EEC) Annex IX No. 1.4]

Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.

[Definition according to (93/42/EEC) Annex IX No. 1.5]

Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

For the purposes of this Directive, 'central circulatory system' means the following vessels:

• arteriae pulmonales,
• aorta ascendens,
• arteriae coronariae,
• arteria carotis communis,
• arteria carotis externa,
• arteria carotis interna,
• arteriae cerebrales,
• truncus brachicephalicus,
• venae cordis,
• venae pulmonales,
• vena cava superior,
• vena cava inferior.

[Definition according to (93/42/EEC) Annex IX No. 1.7]

For the purposes of this Directive, 'central nervous system' means brain, meninges and spinal cord.

[Definition according to (93/42/EEC) Annex IX No. 1.8]

'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 abovementioned prescription may also be made out by any other person authorized 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 are not considered to be custom-made devices.

[Definition according to (93/42/EEC) Article 1 No. 2d].

'Device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex 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 authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner.

[Definition according to (93/42/EEC) Article 1 No. 2e]

'Device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof.

[Definition according to (93/42/EEC) Article 1 No. 2c].

Any device which is intended:

• to be totally introduced into the human body or,
• to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

'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.

[Definition according to (93/42/EEC) Article 1 No. 2g]

A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

Normally intended for continuous use for more than 30 days.

[Definition according to (93/42/EEC) Annex IX No. 1.1]

'Manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling 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. The obligations of this Directive 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. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

[Definition according to (93/42/EEC) Article 1 No. 2f]

'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• 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.

[Definition according to (93/42/EEC) Article 1 No. 2a].

'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 market, regardless of whether it is new or fully refurbished.

[Definition according to (93/42/EEC) Article 1 No. 2h]

'Putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.

[Definition according to (93/42/EEC) Article 1 No. 2i]

Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out.

[Definition according to (93/42/EEC) Annex IX No. 1.3]

Normally intended for continuous use for not more than 30 days.

[Definition according to (93/42/EEC) Annex IX No. 1.1]

An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

Normally intended for continuous use for less than 60 minutes.

[Definition according to (93/42/EEC) Annex IX No. 1.1]