S.I. No. 304/2001 - European Communities (In Vitro Diagnostic Medical Devices) Regulations, 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.

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.

• “(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.

• (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.

• (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 the relevant national standard, unless there are reasonable indications that the device does not comply with that requirement.

• (5)
• (a) Without prejudice to paragraph (4), a device specified in List A or B of Annex II shall be treated as complying with the relevant essential requirements if the device is designed and manufactured in conformity with the common technical specifications drawn up for the device, unless there are reasonable indications that the device does not comply with those requirements.

• (b) A device to which sub-paragraph (a) relates shall be treated as having been manufactured in accordance with the common technical specifications drawn up for the device if, for justifiable reasons, it is not so manufactured but is manufactured in accordance with technical specifications that are at least equivalent to such common technical specifications, unless there are reasonable indications that the device does not comply with those requirements.

CE Marking

• (a) where practicable and appropriate, on the device,

• (b) on the instructions for use, and

• (c) on any sales packaging,

and the marking shall in each case be accompanied by the identification number of the notified body responsible for implementation of the conformity assessment procedures relating to the device as set out in Annexes III, IV, VI and VII.

• (2) Paragraph (1) does not apply to devices for performance evaluation.

• (3) A device shall not be placed on the market bearing a mark or inscription that is likely to mislead a third party with regard to the meaning or the graphics of the CE marking.

• (4) A device may be placed on the market bearing a marking other than the CE marking provided that such other marking, whether affixed on the instructions for use, the sales packaging or the device, does not reduce the visibility and legibility of the CE marking thereon.

• (5) Subject to paragraph (6), where a device comes within the scope of a directive other than the Directive and that directive provides for the affixing of the CE marking, that CE marking shall not be affixed unless the relevant requirements of that other directive are also satisfied.

• (6) Where a directive other than the Directive permits a manufacturer to choose which arrangements to apply during a transitional period, the CE marking shall indicate that the device fulfils only the provisions of those directives applied by the manufacturer and in such a case, the particulars of such directives, as published in the Official Journal of the European Communities, shall be given in the documents, notices or instructions required by the directives and accompanying such devices.

Procedure for affixing CE marking

• (2) A device for self-testing shall bear the CE marking only if its manufacturer follows -

• (a) the relevant EC declaration of conformity procedures specified in Annex III, including the additional requirements set out in paragraph 6 thereof,

• (b) the EC declaration of conformity procedures specified in paragraph (3), or

• (c) the EC declaration of conformity procedures specified in paragraph (4).

• (3) A device specified in List A of Annex II, other than a device intended for performance evaluation, shall bear the CE marking only if its manufacturer either -

• (a) follows the EC declaration of conformity procedure specified in Annex IV, or

• (b) follows the EC type-examination procedure specified in Annex V and the EC declaration of conformity procedure specified in Annex VII.

• (4) A device specified in List B of Annex II, other than a device intended for performance evaluation, shall bear the CE marking only if its manufacturer follows either -

• (a) the EC declaration of conformity procedure specified in Annex IV, or

• (b) the EC type-examination procedure specified in Annex V, and -

• (i) the EC verification procedure specified in Annex VI, or

• (ii) the EC declaration of conformity procedure specified in Annex VII.

• (5) The manufacturer of a device for performance evaluation shall follow the procedures specified in Annex VIII.

General Provisions relating to Conformity Assessment Procedures

• (2) During the course of any procedure to which Regulation 7 applies, the manufacturer of a device and, where appropriate, the notified body shall take account of the results of any assessment and verification operations which have been carried out in accordance with the Directive or these Regulations at an intermediate state of manufacture of the device.

• (3) Any procedure set out in Annexes III, V, VI or VIII which is by virtue of these Regulations to be followed by a manufacturer may be initiated by his authorised representative.

• (4) A manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Competent Authority :

• (a) the declaration of conformity for that device,

• (b) the technical documentation referred to in Annexes III to VIII relating to that device, and

• (c) the decisions, reports and certificates of notified bodies relating to that device,

for a period ending five years after the manufacture of the last product.

• (5) Where any of the procedures to which Regulation 7 applies involves the intervention of a notified body, the manufacturer, or where appropriate his authorised representative, may apply to any notified body designated in accordance with Article 15 of the Directive to carry out tasks in respect of that procedure.

• (6) Where a manufacturer has supplied information or data to a notified body in the course of a procedure to which Regulation 7 relates the notified body may require the manufacturer to provide any additional information or data which the notified body considers necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.

• (7) A decision made by a notified body in accordance with Annex III, IV or V shall be valid for an initial period of not more than 5 years.

• (8) Where an agreement, under which a notified body agrees to carry out for a manufacturer a conformity assessment procedure referred to in Regulation 7, allows the manufacturer to apply to the notified body at a specified time for an extension of the period of validity of a decision mentioned in subparagraph (7), the notified body may extend the period of validity for a period of 5 years.

• (9) Where a period of validity has been extended under subparagraph (8), the notified body may, on an application made by the manufacturer, grant a further extension of 5 years.

• (10) The documentation relating to any of the procedures referred to in this Regulation carried out in the State shall be in English or, subject to Regulation 5(3), in some other language acceptable to the relevant notified body.

• (11) Notwithstanding Regulation 7 in relation to an individual device, the competent authority may authorise the placing on the market or putting into service of an individual device if it is satisfied that this would be in the interest of protection of health.

• (12) The provisions of Regulation 7 and this Regulation shall apply to any person who manufactures devices covered by these Regulations and, without placing them on the market, puts them into service and uses them in the context of his professional activity.

Obligations of persons other than manufacturers.

• (2) Paragraph (1) shall not apply to a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.

Registration of persons placing devices on the market.

• (a) inform the competent authority of his registered address; and

• (b) supply the competent authority -

• (i) in the case of devices being reagents, reagent products and calibration control materials, with information relating to the common technological characteristics or analytes thereof, or both, and of any significant change thereto;

• (ii) in the case of devices to which Annex II applies and devices for self-testing, with a description of the device which is sufficient to identify it, including the analytical and where appropriate, diagnostic parameters as referred to in Annex I, Part A, paragraph 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto.

• (2) In this paragraph “significant change” in relation to a device shall be determined in accordance with the procedures specified in Article 10.5 of the Directive and shall include withdrawing the device from the market.

• (3) When a device to which paragraph (1) (b) (ii) applies or a device for self-testing is placed on the market or put into service, the manufacturer shall, on request by the competent authority, supply a description of the device which is sufficient to identify it and a copy of the label and the instructions for use in respect of the device.

• (4) Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a member state he shall designate an authorised representative.

• (5) An authorised representative having a registered place of business in the State who has been designated in accordance with paragraph (4) shall notify the competent authority in writing of all matters specified in paragraph (1) and shall furnish the competent authority with sufficient evidence that he is the authorised representative of the manufacturer.

(6)(a) Any notification given in accordance with paragraph (1) shall, where the device to which the notification relates is new, specify that fact.

• (b) For the purpose of this paragraph a device shall be considered new if -

• (i) there has been no such device continuously available on the Community market during the previous 3 years for the relevant analyte or other parameter;

• (ii) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community Market during the previous 3 years.

• (c) Where a notification is given in respect of a new device, the competent authority may, at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market.

• (7) The competent authority shall register any notifications received by him in accordance with this Regulation in the European Data Bank referred to in Article 12 of the Directive.

• (8) Pending the establishment of a European databank within the meaning of paragraph (7), a manufacturer who places a device on the market in the State shall give to the competent authority such notification as is required by this Regulation.

Notified bodies.

• (2) For the purposes of paragraph (1), any body that meets the criteria laid down in any relevant national standard transposing any relevant harmonised standard shall be presumed to meet the relevant criteria, unless there are reasonable indications that the body does not comply with the relevant criteria.

• (3) The competent authority may, where it considers that a designated notified body no longer meets the criteria specified in Annex IX, withdraw or restrict the designation of a notified body or vary the tasks for which the notified body has been designated.

• (4) A notified body shall inform -

• (a) every other notified body of any suspension or withdrawal of a certificate issued by it, and

• (b) the competent authority or any other notified body, on request, about any certificate issued or refused by it,

and shall make available to the competent authority or any other notified body, on request, any additional relevant information.

• (5)
• (a) Where a notified body is satisfied that in relation to a certificate issued by it -

• (i) a requirement of these Regulations has not been complied with or is no longer being complied with by the manufacturer, or,

• (ii) a certificate should not have been so issued,

it shall, having regard to the principle of proportionality, suspend or withdraw the certificate or place restrictions on it pending compliance by the manufacturer with such requirement.

• (6) A notified body shall inform the competent authority of any suspension, withdrawal or restriction by it of a certificate and of any circumstances of which it is aware that may necessitate the giving by the competent authority of a direction under Regulation 14.

• (7) Every notified body shall give to the competent authority such information and records, as the competent authority considers necessary for the performance of his functions under this Regulation.

Fees

• (2) Where the costs incurred are greater than the estimated fee, the difference between those costs and that fee shall be payable by the manufacturer or his authorised representative to the notified body, and where those costs are less than the estimated fee, the difference between those costs and that fee shall be repayable by the notified body to the manufacturer or his authorised representative, as the case may be.

Prohibition on placing on the market or putting into service.

• (a) which does not bear the CE marking as required by Regulation 6(1), or

• (b) which bears a mark in contravention of Regulation 6(3).

• (2) The making available to a laboratory or any other institution listed in the statement referred to in Annex VIII of a device intended for performance evaluation is prohibited, unless it complies with the provisions of Regulation 7(5) and Annex VIII.

• (3) Nothing in paragraph (1) shall prevent the showing at a trade fair, exhibition, demonstration, scientific or technical gathering of a device that does not comply with the relevant essential requirements or that does not bear the CE marking provided that such a device is not used on specimens taken from the participants and that a notice is prominently displayed at the event, so as to be readily visible to a prospective purchaser, indicating that the device-

• (a) does not comply with those requirements or does not bear mark; and

• (b) may not be placed on the market or put into service until it complies with the requirements of the Directive.

Temporary Protective Measures

• (a) the health or safety of any person, or

• (b) the safety of any property,

the availability of a device to which these Regulations apply should be prohibited, restricted, or subjected to any particular requirements, or that the device should be withdrawn it may give a temporary direction to that effect.

• (2) Upon giving a temporary direction under paragraph (1), the competent authority shall deliver to the manufacturer or (as the case may) his authorised representative a notice in writing of the direction stating the reasons for it and, in particular, whether those reasons include:

• (a) the failure of the device to comply with a relevant essential requirement,

• (b) the incorrect application of a relevant national standard,

• (c) any shortcoming in the relevant national standard,

and referring the manufacturer or his authorised representative to the provisions of Article 8 of the Directive.

• (3) The manufacturer or (as the case may be) his authorised representative shall comply with any direction given by him under paragraph (1) for the time being in force.

• (4) The competent authority shall inform the Commission of the European Communities of any direction given by it under paragraph (1) and of the reasons for issuing the direction.

• (5) The competent authority may withdraw a direction given by it under this Regulation.

Notification of Decisions.

• (2) Where a device, in respect of which a decision has been taken, has already been granted a CE marking approval in another Member State, the competent authority shall so inform that other Member State and the Commission of the European Communities giving the reasons for the decision.

• (3) The competent authority, or an authorised officer under Regulation 17, and notified bodies in other Member States may obtain from the notified body on request all relevant information submitted concerning the application for CE marking approval of the device and reports of the notified body arising from the application.

Review.

• (a) to refuse to grant a CE marking approval,

• (b) to suspend or withdraw a CE marking approval,

may apply to the competent authority for a review of the decision.

• (2) On reviewing a decision of a notified body under these Regulations, the competent authority—

• (a) shall have the same powers and duties as the notified body has under these Regulations;

• (b) may hold an inquiry in connection with the review; and

• (c) may appoint an assessor.

• (3) An application for a review shall state the grounds on which the application is made and shall be accompanied by the following documents: a copy of the application for a CE marking approval together with every other document submitted to the notified body in connection with that application and a copy of the notice from a notified body referred to in Regulation 15(1).

Authorised Officers.

• (2) An authorised officer shall be furnished with a warrant of appointment as an authorised officer and, when exercising any power conferred on an authorised officer by these Regulations, shall, if requested by any person affected, produce the warrant to that person.

• (3) An authorised officer—

• (a) shall obtain access, on request, to the place of manufacture or storage of devices and to the information referred to in Regulation 8; and

• (b) shall obtain access on request to any ship or other vessel, aircraft, railway wagon or other vehicle in which he has reasonable grounds for believing that devices are being transported for sale in the State or export to a Member State,

and there or at any place make such examinations, tests, or inspections as he may consider appropriate for the purposes of these Regulations.

• (4) An authorised officer—

• (a) may ask the manufacturer of a device, his authorised representative of the person who places the device on the market or puts it into service, to supply the information provided for in Regulation 8 within a period specified by the authorised officer,

• (b) may select a sample of the device and take it away for examination and testing, and

• (c) shall take reasonable measures to guarantee confidentiality with regard to the forwarding of the copies relating to the EC type-examination.

• (5) An authorised officer may require, where the information required to be kept available under Regulation 8 is not available, that the manufacturer or his authorised representative have a test performed at his own expense within the time specified by an approved body to verify compliance with the standard specification applicable to it and the essential safety requirements.

Entry on Premises.

• (a) to seize any device found there which in his opinion could not, without contravening Regulation 5, be placed on the market, and

• (b) to require any person found there to give him his name and address and any other information in his possession in relation to any device referred to in paragraph (a).

• (2) An application under paragraph (1) for an issue of a warrant shall be made to a Judge of the District Court district in which the premises or place to which the application relates is situated.

Service of notices.

• (a) in the case of a person other than the competent authority or a notified body, it shall be addressed to him and may be sent or given to him in some of the following ways:

• (i) by delivering it to him,

• (ii) by leaving it at the address at which he carries on business or ordinarily resides or, in a case in which an address has been furnished under Regulation 10, at that address,

• (iii) by sending it by prepaid registered post in a letter or package addressed to him at the address at which he carries on business or ordinarily resides or, in a case in which an address has been furnished under Regulation 10, at that address;

• (b) in the case of the competent authority or a notified body, paragraph (a) should apply subject to the deletion of “or ordinarily resides”.

• (2) For the purposes of paragraph (1)(a) a company within the meaning of the Companies Act, 1963 , shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or any other place at which it carries on business.

Confidentiality

Offences.

• (a) interfere with an authorised officer in the exercise of his duties under Regulation 18;

• (b) refuse to comply with a request of an authorised officer under Regulation 18;

• (c) disclose or use for business or commercial purposes or any other purpose any information relating to a CE marking approval application in the possession of a notified body without the consent of that body;

• (d) fail to take reasonable measures to guarantee confidentiality with regard to forwarding any documents under Regulation 15(3);

• (e) obstruct or interfere with an authorised officer or member of the Garda Síochána in the exercise of his powers under Regulation 19(1) or to refuse to give information required thereby;

• (f) contravene in any way any provisions or requirement of, or under, Regulation 5, 6, 7, 13, 14(3), 17 or 21.

• (2) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of a director, manager, secretary or other officer of the body corporate, the director, manager, secretary or other officer or any person purporting to act in such capacity shall also be guilty of an offence.

• (3) Subject to the provisions of this Regulation, in criminal proceedings against any person for contravening Regulation 5 it shall be a defence for the person (other than the person established within the Community who first places a device on the market or puts it into service within the Community) to show that he took all reasonable steps and exercised all due diligence to avoid contravening the Regulation.

• (4) A person guilty of an offence under these Regulations shall be liable, on summary conviction, to imprisonment for a period not exceeding six months or to a fine not exceeding €3,000 or to both such imprisonment and fine.

• (5) An offence under these Regulations may be prosecuted by the competent authority.

Transitional provisions.

• (2) Nothing in these Regulations shall prohibit the putting into service before the 27^th day of October, 2005 of a device to which paragraph (1) applies.

	GIVEN under my Official Seal This 29th day of June, 2001.
	Micheál Martin
	Minister for Health and Children

Footnotes