LegalizeS.I. No. 230/2017 - European Union (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations 2017
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
1 amending act · 2022-07-05, S.I. No. 322/2022 - European Union (Equipment and Protective Systems Intended for Use in …
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Regulations 7, 14, 15 and 23
SCHEDULE 5 TEXT OF ANNEX V TO THE DIRECTIVE
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the Directive that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of the Directive that apply to them.
3. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EU-type examination certificate and with the appropriate requirements of the Directive.
The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4.
4. Verification of conformity by examination and testing of every product
4.1. All products shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of the Directive.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual product other than a component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of the Directive.
5.2. The manufacturer shall draw up a written EU declaration of conformity for each product model other than a component and keep it at the disposal of the national authorities, for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.
A copy of the EU declaration of conformity shall accompany every product other than a component.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the products other than components.
5.3. The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.
The notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the products during the manufacturing process.
7. Authorised representative
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.
Regulations 7, 14, 15 and 23
SCHEDULE 6 TEXT OF ANNEX VI TO THE DIRECTIVE
MODULE C1: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING
Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the Directive that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the EU-type examination certificate and with the requirements of the Directive that apply to them.
3. Product checks
For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the type described in the EU- type examination certificate and with the corresponding requirements of the Directive. The tests shall be carried out under the responsibility of a notified body, chosen by the manufacturer.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
4. CE marking, EU declaration of conformity and attestation of conformity
4.1. The manufacturer shall affix the CE marking to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of the Directive.
4.2. The manufacturer shall draw up a written EU declaration of conformity for a product model other than a component and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.
A copy of the EU declaration of conformity shall accompany every product, other than a component.
4.3. The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Regulations 7, 14, 15 and 23
SCHEDULE 7 TEXT OF ANNEX VII TO THE DIRECTIVE.
MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE
Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the Directive that apply to them.
2. Manufacturing
The manufacturer shall operate an approved quality system for the final inspection and testing of equipment as specified in paragraph 3 below and shall be subject to surveillance as specified in paragraph 4 below.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system for the products concerned with a notified body of his choice.
The application shall include:
- (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
- (b) a written declaration that the same application has not been lodged with any other notified body,
- (c) all relevant information for the product category envisaged,
- (d) the documentation concerning the quality system, and
- (e) the technical documentation of the approved type and a copy of the EU-type examination certificate.
3.2. The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of the Directive.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instruments. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall contain, in particular, an adequate description of:
- (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
- (b) the examinations and tests that will be carried out after manufacture;
- (c) the quality records, such as inspection reports and test data, calibration data, reports on the personnel concerned, etc.
- (d) the means of monitoring the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of the Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(e) in order to verify the manufacturer’s ability to identify the relevant requirements of the Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer shall for inspection purposes allow the notified body access to the inspection, testing and storage premises and shall provide it with all necessary information, in particular:
- (a) quality system documentation;
- (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of the Directive.
5.2. The manufacturer shall draw up a written EU declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.
A copy of the EU declaration of conformity shall accompany every product other than a component.
5.3. The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.
The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:
- (a) the documentation referred to in point 3.1,
- (b) the information relating to the change referred to in point 3.5, as approved,
- (c) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Regulations 7, 14 and 15
SCHEDULE 8 TEXT OF ANNEX VIII TO THE DIRECTIVE
MODULE A: INTERNAL PRODUCTION CONTROL
Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the Directive that apply to them.
2. Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:
- (a) a general description of the product,
- (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
- (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,
- (d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
- (e) results of design calculations made, examinations carried out, etc., and
- (f) test reports.
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the Directive that apply to them.
4. CE marking, EU declaration of conformity and attestation of conformity
4.1. The manufacturer shall affix the CE marking to each individual product other than a component that satisfies the applicable requirements of the Directive.
4.2. The manufacturer shall draw up a written EU declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.
A copy of the EU declaration of conformity shall accompany every product other than a component.
4.3. The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Regulations 7, 14, 15 and 23
SCHEDULE 9 TEXT OF ANNEX IX TO THE DIRECTIVE
MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of the Directive that apply to it.
2. Technical documentation
2.1. The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the product’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:
- (a) a general description of the product,
- (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
- (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,
- (d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
- (e) results of design calculations made, examinations carried out, etc., and
- (f) test reports.
2.2. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the Directive.
4. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of the Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each product other than a component that satisfies the applicable requirements of the Directive.
5.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The EU declaration of conformity shall identify such product for which it has been drawn up.
A copy of the EU declaration of conformity shall accompany every product, other than a component.
5.3. The manufacturer shall draw up a written attestation of conformity and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.
6. Authorised representative
The manufacturer's obligations set out in points 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Regulation 15
SCHEDULE 10 TEXT OF ANNEX X TO THE DIRECTIVE
EU DECLARATION OF CONFORMITY (No XXXX)6
Product model/product (product, type, batch or serial number):
Name and address of the manufacturer and, where applicable, his authorised representative:
This declaration of conformity is issued under the sole responsibility of the manufacturer.
Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image):
The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:
Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:
Additional information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
Regulation 2
SCHEDULE 11 TEXT OF ANNEX XII TO THE DIRECTIVE
CORRELATION TABLE
| Directive 94/9/EC | Directive 2014/33/EU |
| Article 1(1) | Article 1(1)(a) |
| Article 1(2) | Article 1(1)(b) |
| — | Article 1(1)(c) |
| Article 1(3) | Article 2(1) to (9) |
| — | Article 2(10) to (26) |
| Article 1(4) | Article 1(2) |
| Article 2 | Article 3 |
| Article 3 | Article 4 |
| Article 4 | Article 5 |
| Article 5(1), first subparagraph | — |
| Article 5(1), second subparagraph | Article 12(2) |
| Article 5(2) | Article 12(1) |
| Article 5(3) | — |
| — | Articles 6 to 11 |
| — | — |
| Article 6(1) and (2) | — |
| Article 6(3) | Article 39(1) to (4) |
| — | Article 39(5), first subparagraph |
| Article 6(4) | Article 39(5), second subparagraph |
| Article 7 | — |
| Article 8(1) to (6) | Article 13(1) to (6) |
| Article 8(7) | — |
| — | Articles 14 and 15 |
| Article 9 | — |
| Article 10(1) | — |
| Article 10(2) | Article 16(1) |
| Article 10(3) | — |
| — | Article 16(2) to (6) |
| — | Articles 17 to 33 |
| Article 11 | — |
| — | Articles 34 to 38 |
| Articles 12 and 13 | — |
| — | Article 40 |
| — | Article 41(1) |
| Article 14(1) | — |
| Article 14(2) | Article 41(2) |
| Article 14(3) | — |
| Article 15(1) | Article 42(1) |
| Article 15(2) | — |
| — | Article 42(2) |
| — | Articles 43 and 44 |
| Article 16 | Article 45 |
| Annexes I to IX | Annexes I to IX |
| Annex X | — |
| Annex XI | — |
| — | Annex X |
| — | Annex XI |
| — | Annex XII |
GIVEN under my Official Seal,
26 May 2017.
MARY MITCHELL O’CONNOR,
Minister for Jobs, Enterprise and Innovation.
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal interpretation.)
These Regulations transpose into national legislation the provisions of Directive 2014/34/EU which set out the requirements for the making available on the market and putting into service, as well as the essential health and safety requirements relating to the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres, (known as ATEX). These Regulations also set out the obligations on economic operators in relation to these products and the required conformity assessment procedures for such ATEX products. These Regulations also give further effective to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93 and include duties to have proper market surveillance procedures consistent with EU Regulation 765/2008.
These Regulations do not impede the making available on the market of products covered by Directive 94/9/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.
The Regulations revoke and replace the European Communities (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations 1999, ( S.I. No. 83 of 1999 ).
Footnotes
OJ No. L 96, 29.3.2014, p.309.
OJ No. L. 218, 13.8.2008, p.30.
OJ No. L 100, 19.4.1994, p.1.
OJ No. L 316, 14.11.2012, p.12.
OJ No. L 399, 30.12.89, p.18.
It is optional for the manufacturer to assign a number to the declaration of conformity.
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