STATUTORY INSTRUMENT

S.I. No. 444 of 2001

EUROPEAN COMMUNITIES (MEDICAL DEVICES) (AMENDMENT) REGULATIONS, 2001

DUBLIN

PUBLISHED BY THE STATIONERY OFFICE

Statutory Instrument No. 444 of 2001

EUROPEAN COMMUNITIES (MEDICAL DEVICES) (AMENDMENT) REGULATIONS, 2001

I, Micheál 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 Council Directive 93/42/EEC¹ of 14 June 1993 concerning medical devices, as amended by Directive 98/79/EC² of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices and for the purposes of giving full effect to Directive 90/385/EEC³ of 20 June 1990 on the approximation of the law of the Member States relating to active implantable medical devices, hereby make the following Regulations:

Citation and commencement

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

2. (1) Section 4(1) of the Irish Medicines Board Act, 1995 is hereby amended by the addition of the following paragraph after paragraph (o) inserted by the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ):

“(p) to exercise the powers conferred on the competent authority by Council Directive 90/385/EEC of 20 June 1990⁴ and the European Communities (Active Implantable Medical Devices) Regulations, 1994 ( S.I. No. 253 of 1994 ) and Council Directive 93/42/EC of 14 June 1993⁵ and the European Communities (Medical Devices) Regulations, 1994 ( S.I. No. 252 of 1994 ).”

(2) For the purposes of Council Directive 90/385/EEC of 20 June 1990 and Council Directive 93/42/EC of 14 June 1993 the competent authority in the State shall be the Irish Medicines Board established by the Irish Medicines Board Act, 1995 .

(3) For the purposes of the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 1994 ), and the European Communities (Medical Devices) Regulations, 1994 ( S.I. No. 252 of 1994 ) where the word “Minister” appears, the words “Competent Authority” should be substituted, save in Article 2(1) of both regulations.

3. The regulations will come into operation on 1 October 2001.

Definition

4. In these Regulations “the Principal Regulations” means the European Communities (Medical Devices) Regulations, 1994 ( S.I. No. 252 of 1994 ).

Amendment of Principal Regulations

5. Article 2 of the Principal Regulations is hereby amended:

(a) in sub-article (1) -

(i)       by the substitution for the definition of “authorised representative” of the following definition:

‘“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 ;’,

(ii)      by the insertion after “devices⁽²⁾” in the definition of “the Directive” of the following:

‘as amended by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices’,

(iii)     by the insertion after the definition of “essential requirements” of the following definition:

‘“function” includes powers and duties and references to the performance of a function include, in relation to a power or a duty, references to the exercise of the power or the carrying out of the duty;’,

(iv)     by the insertion after the definition of “intended purpose” of the following definition:

‘“in vitro diagnostic medical device” means a medical device, that is to say a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, which is 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) 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 its manufacturer to be used for in vitro diagnostic examination;’,

(v)      by the substitution for the definition of “putting into service” of the following definition:

‘“putting into service” means, in relation to a device, making 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;’,

(vi)     by the insertion after the definition of “relevant notified body identification number” of the following definition:

‘“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;’,

(vii)    by the deletion of the definition of “used for in vitro diagnosis”, and

(b)       in sub-article (4) -

by the substitution for “Council Directive 93/42/EEC” of “the Directive”.

6. Article 3 of the Principal Regulations is hereby amended in sub-article (4) by the substitution for paragraph (a) of the following:

“(a) in vitro diagnostic medical devices;”.

7. The Principal Regulations are hereby amended by the insertion after Article 14(3)(b) of the following:

“(c) and shall furnish the Competent Authority with sufficient evidence that he is the authorised representative of the manufacturer.”

8. The Principal Regulations are hereby amended by the insertion after Article 14 of the following Article:

Information relating to Class IIb and III devices.

“14A A person who puts into service a Class IIb or III device in the State shall supply the Competent Authority on request with -

(a) a description of the device which is sufficient to identify it, and

(b) a copy of the label and the instructions for use relating to such device.”.

9. Article 17 of the Principal Regulations is hereby amended by the insertion of the following sub-articles after sub-article (2):

“(3) A notified body shall inform -

(a) the Competent Authority and every other notified body of any suspension or withdrawal of CE Marking approval issued by it,

(b) the Competent Authority or any other notified body, on request, of any CE Marking approval issued or refused by it,

and shall make available, on request, any additional relevant information.

(4)(a) Where a notified body is satisfied that in relation to a CE Marking approval 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 CE Marking approval should not have been so issued, it shall, having regard to the principle of proportionality, suspend or withdraw the CE Marking approval or place restrictions on it pending compliance by the manufacturer with such requirement.

(b) A notified body shall inform the Competent Authority of -

(i) any suspension or withdrawal by it of a CE Marking approval, or

(ii) any circumstances of which it is aware that may necessitate the giving by the Competent Authority of a direction under article 20A (inserted by the European Communities (Medical Devices) (Amendment) Regulations, 2001).

(5) The Competent Authority may request that a notified body supply to it any or all relevant information and documents, including budgetary documents, necessary to enable it to verify that the body meets the criteria set out in Annex XI, and a notified body shall supply to it any or all the relevant information and documents so requested.”.

10. The Principal Regulations are hereby amended by the insertion after Article 19 of the following Regulations :

“19(A)(1) Where the Competent Authority is satisfied that a device bearing the CE marking does not comply with a requirement of these Regulations, whether in respect of the device itself or the CE marking thereon, it shall notify the manufacturer or his authorised representative in writing of that fact and shall request the manufacturer or his authorised representatives to comply with the requirement within the time specified in the notice.

The provisions of 19(A)(1) shall apply where the CE Marking has been affixed in accordance with the procedures in these Regulations, but inappropriately, on products that are not covered by this Directive.

(2) A manufacturer or his authorised representatives who has been served with a notice under sub-article (1) shall comply with the notice.

(3) Where a manufacturer or an authorised representative to whom sub-article(2) applies, fails to comply with a notice under article (1), the Competent Authority may, by notice in writing delivered to the manufacturer or the authorised representative, direct the manufacturer or the authorised representative to withdraw the device from the market, or may restrict or prohibit the placing on the market of the device.

(4) A manufacturer or authorised representative who has been served with a notice under sub-article (3) shall comply with the notice.

(5) The Competent Authority shall, in accordance with the procedures set out in Article 8 of the Directive, inform the Commission of any steps taken by it under article (3).

(6) The Competent Authority may withdraw a notice issued by it under this Regulation.

19(B) Where a competent authority ascertains that the devices referred to in Article 4 (1) and (2) second indent of the Council Directive 93/42/EEC when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.”.

11. The Principal Regulations are hereby amended by the insertion after Article 20 of the following Article:

Temporary Protective Measures.

“20A.     (1)Where the Competent Authority considers that, in order to ensure protection of health and safety or to ensure that public health requirements are observed in accordance with Article 36 of the Treaty of Rome, the availability of any device should be prohibited, restricted or subjected to any particular requirements, it may give a temporary direction to that effect.

(2)Upon giving a temporary direction under sub-article (1) the Competent Authority shall deliver to the manufacturer or (as the case may be) his authorised representative a notice in writing of the direction stating the exact grounds on which it is based and referring the manufacturer or his authorised representative to the provisions of Article 14b of the Directive.

(3)The manufacturer or (as the case may be) his authorised representative shall comply with any direction given under sub-article (1) and for the time being in force.

(4) The Competent Authority shall inform the Commission of the European Communities and every other Member State of any direction given by it under sub-article (1) and of the reasons for issuing the direction.

(5)The Competent Authority may withdraw a direction given by it under this Regulation.”.

12. The Principal Regulations are hereby amended by the insertion after Article 24 of the following Article:

“24(A).  Except as otherwise provided for in these Regulations, and subject to any requirement under criminal law, a person shall not disclose to any other person any information obtained by him or her in the performance of his or her functions under these Regulations.”.

13. Article 26 of the Principal Regulations are hereby amended in paragraph (f) of sub-article (1) by the substitution for “5, 6, 19 or 22” of “5, 6, 19, 19A, 20A, 22 or 24A”.

14. The Principal Regulations are hereby amended in Schedule II by the deletion of section 6.2 therefrom.

15. The Principal Regulations are hereby amended in Schedule III by the deletion of section 7.1 therefrom.

16. The Principal Regulations are hereby amended in Schedule V by the deletion of section 5.2 therefrom.

17. The Principal Regulations are hereby amended in Schedule VI by the deletion of section 5.2 therefrom.

18. The Principal Regulations are hereby amended in Schedule X section 1.1 by the substitution of “Sections 1 and 3 of Schedule 1” for “Sections 1 and 2 of Schedule 1”.

19. The Principal Regulations are hereby amended in Schedule XI by the insertion after the second sentence in section 3 of the following sentence:

“This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I.”.

20. The European Communities (Active Implantable Medical Devices) Regulations, 1994, are hereby amended by the insertion after Article 13 of the following Regulations :

“13(A)(1) Where the Competent Authority is satisfied that a device bearing the CE marking does not comply with a requirement of these Regulations, whether in respect of the device itself or the CE marking thereon, it shall notify the manufacturer or his authorised representative in writing of that fact and shall request the manufacturer or his authorised representatives to comply with the requirement within the time specified in the notice.

(2) A manufacturer or his authorised representatives who has been served with a notice under sub-article (1) shall comply with the notice.

(3) Where a manufacturer or an authorised representative to whom sub-article(2) applies, fails to comply with a notice under article (1), the Competent Authority may, by notice in writing delivered to the manufacturer or the authorised representative, direct the manufacturer or the authorised representative to withdraw the device from the market, or may restrict or prohibit the placing on the market of the device.

(4) A manufacturer or authorised representative who has been served with a notice under sub-article (3) shall comply with the notice.

(5) The Competent Authority shall, in accordance with the procedures set out in Article 8 of the Directive, inform the Commission of any steps taken by it under article (3).

(6) The Competent Authority may withdraw a notice issued by it under this Regulation.

13(B) Where a competent authority ascertains that the devices referred to in Article 4 (1) and (2) second indent of the Council Directive 90/385/EEC when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.”.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation)

These regulations amend the European Communities (Medical Devices) Regulations, 1994 ( S.I. No. 252 of 1994 ) and the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 1994 ) to give effect to Council Directive 98/79/EEC of 27th October 1998 (OJ No. L 331, 07.12.1998, p.1.), and assign the function of Competent Authority with respect to the aforementioned regulations to the Irish Medicines Board.

¹ OJ No. L169 12.7.1993, p. 1

² OJ No. L331 7.12.1998, p. 1

³ OJ No. L189 20.7.1990, p. 0017 - 0036

⁴ OJ No. L189 20.7.1990, p. 0017 - 0036

⁵ OJ No. L169 12.7.1993, p.1.