European Communities (Medical Devices) (Amendment) Regulations, 2001

• Jurisdiction: Ireland
• Citation: IR SI 444/2001
• Year: 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...