European Communities (In Vitrodiagnostic Medical Devices) Regulations, 2001

• Jurisdiction: Ireland
• Citation: IR SI 304/2001
• Year: 2001

I, Micháel Martin, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving full effect to Directive 98/79/EC1 of the European Parliament and of the Council of 27 October 1998, on in vitro diagnostic medical devices, hereby make the following Regulations:

Citation

1. These Regulations may be cited as the European Communities (In Vitro Diagnostic Medical Devices) Regulations, 2001.

2.(1) In these Regulations -

“accessory” means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with such a device to enable the device to be used as intended by its manufacturer, but does not include -

(i) an invasive sampling medical device, or

a medical device that is directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC2 ;

“Annex” means an Annex to the Directive;

“authorised officer” means a person appointed under Regulation 17 to be an authorised officer for the purposes of these Regulations;

“authorised representative” means a person established within the Community who, explicitly designated by the manufacturer, acts for the manufacturer and may be addressed by authorities and bodies in the Community instead of the manufacturer under and in accordance with these regulations;

“CE marking”, means the EC mark of conformity consisting of the symbol ‘CE’; a specimen form of which is set out in Annex 10;

“device”, except where otherwise stated, means an in vitro diagnostic medical device and includes an accessory to such a device;

“device for performance evaluation” means any device intended by the manufacturer to be subject to one or more performance evaluation studies carried out in a laboratory or other appropriate environment outside of the manufacturer's own premises;

“device for self-testing” means any device intended by the manufacturer to be able to be used by lay persons in a home environment;

“the Directive” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998, on in vitro diagnostic medical devices;

“essential requirements” means the requirements specified in Schedule 1 and “relevant essential requirements” in relation to a device means such of those requirements, or such aspects of those requirements, as apply to it, having regard to its intended purpose;

“harmonised standard” has the meaning it has in Article 5 of the Directive;

“intended purpose” means, in relation to a device, the use for which it is intended according to the data supplied by the manufacturer-

(i) on the labelling,

(ii) in the instructions for use, and

(iii) in any promotional materials;

“in vitro diagnostic medical device” means a medical device being 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

(b) concerning a congenital abnormality

(c) for the purpose of determining the safety and compatibility with potential recipients, or

(d) for the purpose of monitoring a therapeutic measure,

and includes a specimen receptacle but does not include a product for general laboratory use unless such product, in view of its characteristics, is specifically intended by the manufacturer to be used for in vitro diagnostic examination;

“manufacturer” means the natural or legal person responsible 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;

“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 -

(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) or 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;

“Member State” means a Member State of the European Union;

“the Minister” means the Minister for Health and Children;

“notified body” means, in relation to any task, a body designated and notified by the competent authority in respect of that task in accordance with Article 15 of the Directive;

“placing on the market” means, in relation to a device, except where otherwise expressly stated, the first making available, whether in return for payment or free of charge, of a fully refurbished or new device, other than a device intended for performance evaluation, with a view to distribution, use, or both, in the Community, and cognate expressions shall be construed accordingly;

“putting into service” means, in relation to a device, marking it available to the ultimate user for use in the State for the first time for its intended purpose, and cognate expressions shall be construed accordingly;

“relevant national standard” means, in relation to an essential requirement or an aspect of it—

(a) a standard specification declared in accordance with section 16 of the National Standards Authority of Ireland Act, 1996 (No. 28 of 1996), or

(b) a standard declared or laid down by a body or person pursuant to the law of another Member State,

which conforms to a harmonised standard to which the Directive applies;

“relevant notified body identification number” means the identification number of the notified body which was responsible for carrying out tasks of the notified body under Annexes III, IV, V, VI or VII as respects a procedure which has been followed by the manufacturer of a device, and, where there is more than one such notified body, means the identification number of each of them;

“specimen receptacle” means a device, whether vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation for the purpose of in vitro diagnostic examination of specimens derived from the human body.

(2) A reference in these Regulations to a Regulation is to a Regulation of these Regulations and a reference in these Regulations to an Annex is to an Annex of the Directive, unless it is indicated that reference to some other enactment is intended.

(3) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other enactment is intended.

(4) A word or expression that is used in these Regulations and is also used in the Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Directive.

3. (1) Section 4(1) of the Irish Medicines Board Act, 1995 is hereby amended by the addition of the following paragraph after (n):

“(o) to exercise the powers conferred on the competent authority by Council Directive 98/79/EC of the 27th October, 19983 and the European Communities (In Vitro Diagnostic Medical Devices) Regulations, 2001”

(2) For the purposes of the Directive and these Regulations the competent authority in the State shall be the Irish Medicines Board established by the Irish Medicines Board Act, 1995 .

Application.

4. (1) Subject to subparagraph (1), these Regulations shall apply to in vitro diagnostic medical devices and their accessories and, for the purposes of these Regulations, accessories shall be treated as in vitro diagnostic medical devices in their own right.

(1) These Regulations do not apply to in vitro diagnostic medical devices and their accessories which are manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity.

(2) For the purposes of these Regulations, calibration and control materials refer to any substance, material or article intended by the manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device.

(3) The Directive is a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC4 , which last mentioned directive shall cease to apply to devices which have complied with this Directive.

Essential requirements for devices.

5. (1) All devices placed on the market or put into service must comply with the relevant essential requirements. This applies also to devices made available for performance evaluation.

(2) In determining which are the relevant essential requirements for a device and whether or not the device complies with any of the relevant essential requirements account shall be taken of its intended purpose.

(3) For the purposes of this Regulation, the information relating to the device to be supplied by the manufacturer in accordance with section 8, of Part B, of Annex I, shall be supplied in the English language, whether or not it is also in another language and whether or not the device is for professional or other use.

(4) A device shall be treated as complying with an essential requirement if, as respects that requirement, it complies with...