European Communities (Medical Devices) (Amendment) Regulations, 2009

• Jurisdiction: Ireland
• Citation: IR SI 110/2009
• Year: 2009

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 3rd April, 2009.

I, MARY HARNEY, 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 2007/47/EC of 5 September 2007 amending Council Directive 93/42/EEC of 14 June 1993 ( S.I. No. 252 of 1994 ) concerning medical devices, hereby make the following Regulations:

1. These following Regulations may be cited as the European Communities (Medical Devices) (Amendment) Regulations 2009. These Regulations shall come into force on 21 March 2010.

2. In these Regulations:

“The Principal Regulations” means the European Communities (Medical Devices) Regulations, 1994 (Statutory Instrument number 252 of 1994).

“These Regulations” means the European Communities (Amendment) Regulations 2009 amending the Principal Regulations.

“The Directive” means the Directive 2007/47/EC (1) of the European Parliament and Council of 5 September 2007 amending Directive 90/385/EEC relating to Active Implantable Medical Devices 93/42/EEC relating to medical devices and 98/8/EEC relating to placing of biocidal products on the market.

“Directive 90/385/EEC” means Directive 90/385/EEC (2) of the European Parliament and Council of 20 June 1990 concerning Active Implantable Medical Devices.

“Directive 93/42/EEC” means Directive 93/42/EEC (3) of the European Parliament and Council of 14 June 1993 concerning Medical Devices.

“Directive 2001/83/EC” means Directive 2001/83/EC (4) of the European Parliament and Council of 6 November 2001 concerning the Community code relating to Medicinal Products for Human Use.

“Directive 2004/108/EC” means Directive 2004/108/EC (5) of the European Parliament and Council of the 15 December 2004 concerning electromagnetic compatibility.

“Directive 2006/42/EC” means Directive 2006/42/EC (6) of the European Parliament and of the Council of 17 May 2006 on machinery.

“European Communities (Medical Ionising Radiation Protection) Regulations ( S.I. No. 478 of 2002 )” means the European Communities (Medical Ionising Radiation Protection) Regulations of 15 October 2002 (Statutory Instrument number 478 of 2002).

“European Communities (Personal Protective Equipment) Regulations ( S.I. No. 272 of 1993 )” means European Communities (Personal Protective Equipment) Regulations of 22 September 1993 (Statutory Instrument number 272 of 1993).

“Medicinal Products (Control of Placing on the Market) Regulations ( S.I. No. 540 of 2007 )” means Medicinal Products (Control of Placing on the Market) Regulations of 20 July 2007 (Statutory Instrument number 540 of 2007).

“Radiological Protection Act 1991 Ionising Radiation order ( S.I. No. 125 of 2000 )” means Radiological Protection Act 1991 Ionising Radiation order of 13 May 2000 (Statutory Instrument number 125 of 2000).

3. A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.

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 provision is intended.

A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.

4. Regulation 2 (Definitions) of the Principal Regulations is amended:

(i) by the insertion after the definition of “CE marking” of the following definition:

“clinical data” means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

— clinical investigation(s) of the device concerned; or

— clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

— published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;’

(ii) by the insertion after the definition of “device” of the following definition:

“device subcategory” means a set of devices having common areas of intended use or common technology;’

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

“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

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

‘single use device” means a device intended to be used once only for a single patient;

5. Regulation 2 (Definitions) of the Principal Regulations is amended by the following changes in the definitions:

(i). The definition of “custom made device” is amended by deleting the words:

“but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the registered medical practitioner or professional user;”

and substituting the words:

“but shall not include a mass-produced product which needs to be adapted to meet the specific requirements of the registered medical practitioner or professional user;”

(ii). The definition of “device” is amended by substituting for the words:

‘“device” means a medical device, that is to say an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which—

(a) is intended by the manufacturer to be used for human beings for the purpose of—

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or

(iv) control of conception; and

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means;’

with the words:

‘“device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of—

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or

(iv) control of conception; and

does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means;

(iii). The definition for “intended for clinical investigation” is deleted and substituted with the following words:

‘“intended for clinical investigation” means, in relation to a device, that it is—

(a) intended for use by a registered medical practitioner user when conducting investigations of that device in an adequate human clinical environment; or

(b) for use by any other person who by virtue of his or her professional qualifications is authorised to carry out investigations of that device in an adequate human clinical environment;

6. Regulation 3 (Application) of the Principal Regulations is amended by deleting Paragraph (2) and substituting the following words:

“(2)Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, that device shall be governed by these Regulations, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Schedule 1 to these Regulations shall apply as far as safety and performance-related device features are concerned.”

7. Regulation 3 (Application) of the Principal Regulations is amended by deleting Paragraph (3) before paragraph 3(a) and substituting the words:

“(3)Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorised in accordance with these Regulations.”

8. Regulation 3 (Application) of the Principal Regulations is amended by deleting Paragraph (3)(a) and substituting the following:

“(3)(a)Where a device incorporates as an integral part a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a “human blood derivative”, that device shall be assessed and authorised in accordance with these Regulations.”

9. Regulation 3 (Application) of the Principal Regulations is amended by deleting all the words in Paragraph (4)(c) and substituting the...