S.I. No. 136/2018 - European Union (Personal Protective Equipment) Regulations 2018

• (h) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements;

• (i) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class;

• (j) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications;

• (k) a copy of the manufacturers instructions and information set out in point 1.4 of Annex II;

• (l) for PPE produced as a single unit to fit an individual user, all the necessary instructions for manufacturing such PPE on the basis of the approved basic model;

• (m) for PPE produced in series where each item is adapted to fit an individual user, a description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of PPE complies with the approved type and with the applicable essential health and safety requirements.

Regulations 14 and 15

SCHEDULE 4 Text of Annex IV to the PPE Regulation

INTERNAL PRODUCTION CONTROL

(Module A)

The manufacturer shall establish the technical documentation described in Annex III.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured PPE with the technical documentation referred to in point 2 and with the applicable requirements of this Regulation.

The manufacturers 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 14 and 23

SCHEDULE 5 Text of Annex V to the PPE Regulation

EU TYPE-EXAMINATION

(Module B)

The manufacturer shall lodge an application for EU type-examination with a single 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) the technical documentation described in Annex III;

• (d) the specimen(s) of the PPE representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme. For PPE produced in series where each item is adapted to fit an individual user, specimens shall be provided that are representative of the range of different users, and for PPE produced as a single unit to accommodate the special needs of an individual user, a basic model shall be provided.

The notified body shall:

• (a) examine the technical documentation to assess the adequacy of the technical design of the PPE. In conducting such an examination, point (j) of Annex III need not be taken into account;

• (b) for PPE produced in series where each item is adapted to fit an individual user, examine the description of the measures to assess their adequacy;

• (c) for PPE produced as a single unit to fit an individual user, examine the instructions for manufacturing such PPE on the basis of the approved basic model to assess their adequacy;

• (d) verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the elements which have been designed in accordance with other technical specifications;

• (e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;

• (f) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential health and safety requirements and have been applied correctly.

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

• (a) the name and identification number of the notified body;

• (b) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the latters name and address;

• (c) identification of the PPE covered by the certificate (type number);

• (d) a statement that the PPE type complies with the applicable essential health and safety requirements;

• (e) where harmonised standards have been fully or partially applied, the references of those standards or parts thereof;

• (f) where other technical specifications have been applied, their references;

• (g) where applicable, the performance level(s) or protection class of the PPE;

• (h) for PPE produced as a single unit to fit an individual user, the range of permissible variations of relevant parameters based on the approved basic model;

• (i) the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;

• (j) any conditions attached to the issue of the certificate;

• (k) for category III PPE, a statement that the certificate shall only be used in conjunction with one of the conformity assessment procedures referred to in point (c) of Article 19.

• (a) in the case of a modification to the approved type referred to in point 7.2;

• (b) in the case of a change in the state of the art referred to in point 7.3;

• (c) at the latest, before the date of expiry of the certificate.

In order to allow the notified body to fulfil its tasks, the manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate.

• (a) his name and address and data identifying the EU type-examination certificate concerned;

• (b) confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant harmonised standards or other technical specifications applied;

• (c) confirmation that there has been no change in the state of the art as referred to in point 7.3;

• (d) where not already supplied, copies of current product drawings and photographs, product marking and information supplied by the manufacturer; and

• (e) for category III products, where not already available to the notified body, information on the results of the supervised product checks at random intervals carried out in accordance with Annex VII, or on the results of audits of his quality system carried out in accordance with Annex VIII.

Where the notified body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out. In such cases, the notified body shall renew the EU type-examination certificate.

The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure.

If the notified body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply.

Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type- examination certificates and/or additions thereto. On a reasoned request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.

Regulations 14 and 15

SCHEDULE 6 Text of Annex VI to the PPE Regulation

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

(Module C)

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured PPE with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation.

3.1. The manufacturer shall affix the CE marking to each individual PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.

3.2. The manufacturer shall draw up a written EU declaration of conformity for a PPE model and keep it at the disposal of the national authorities for 10 years after the PPE has been placed on the market. The EU declaration of conformity shall identify the PPE for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

The manufacturers obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Regulations 14, 15, 17 and 23

SCHEDULE 7 Text of Annex VII to the PPE Regulation

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS

(Module C2)

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of production and conformity of the manufactured PPE with the type described in the EU type- examination certificate and with the applicable requirements of this Regulation.

Before placing PPE on the market, the manufacturer shall lodge an application for supervised product checks at random intervals with a single notified body of his choice.

The application shall include the following:

• (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address;

• (b) a written declaration that the same application has not been lodged with any other notified body;

• (c) the identification of the PPE concerned.

Where the chosen body is not the body that has carried out the EU type-examination, the application shall also include the following:

• (a) the technical documentation described in Annex III;

• (b) a copy of the EU type-examination certificate.

4.1. The notified body shall carry out product checks in order to verify the homogeneity of production and the conformity of the PPE with the type described in the EU type-examination certificate and with the applicable essential health and safety requirements.

4.2. The product checks shall be carried out at least once a year, at random intervals determined by the notified body. The first product checks shall be carried out no more than one year after the date of issue of the EU type- examination certificate.

4.3. An adequate statistical sample of the manufactured PPE shall be selected by the notified body at a place agreed between the body and the manufacturer. All items of PPE of the sample shall be 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 the conformity of the PPE with the type described in the EU type- examination certificate and with the applicable essential health and safety requirements.

4.4. Where the notified body referred to in point 3 is not the body that issued the relevant EU type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample.

4.5. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production and performs within acceptable limits, with a view to ensuring conformity of the PPE.

4.6. If the examination and testing reveal that the production is not homogeneous, or that the PPE does not comply with the type described in the EU type-examination certificate or with the applicable essential health and safety requirements, the notified body shall take measures appropriate to the fault(s) recorded and inform the notifying authority thereof.

5.1. The notified body shall provide the manufacturer with a test report.

5.2. The manufacturer shall keep the test report at the disposal of the national authorities for 10 years after the PPE has been placed on the market.

5.3. The manufacturer shall, under the responsibility of the notified body, affix the notified bodys identification number during the manufacturing process.

6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latters identification number to each individual item of PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.

6.2. The manufacturer shall draw up a written EU declaration of conformity for each PPE model and keep it at the disposal of the national authorities for 10 years after the PPE has been placed on the market. The EU declaration of conformity shall identify the PPE model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

The manufacturers 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 manufacturers obligations set out in point 2.

Regulations 14, 15, 17 and 23

SCHEDULE 8 Text of Annex VIII to the PPE Regulation

CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

(Module D)

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the PPE concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

3.1. The manufacturer shall lodge an application for assessment of his quality system with a single 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) the address of the manufacturers premises where the audits can be carried out;

• (c) a written declaration that the same application has not been lodged with any other notified body;

• (d) the identification of the PPE concerned;

• (e) the documentation concerning the quality system.

Where the chosen body is not the body that has carried out the EU type-examination, the application shall also include the following:

• (a) the technical documentation of the PPE described in Annex III;

• (b) a copy of the EU type-examination certificate.

3.2. The quality system shall ensure that the PPE is in conformity with the type described in the EU type-examination certificate and complies with the applicable requirements of this Regulation.

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 instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

The quality system documentation shall, in particular, contain 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 corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

• (c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

• (d) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and

• (e) the means of monitoring the achievement of the required product quality and 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 point 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 field of PPE and technology concerned, and knowledge of the applicable essential health and safety requirements. The audit shall include an assessment visit to the manufacturers premises. The auditing team shall review the technical documentation of the PPE referred to in point 3.1 to verify the manufacturers ability to identify the applicable essential health and safety requirements and to carry out the necessary examinations with a view to ensuring conformity of the PPE with those requirements. The result of that assessment shall be notified to the manufacturer. The notification shall contain the conclusions of the audit 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.

3.6. The notified body shall authorise the manufacturer to affix the notified bodys identification number to each individual item of PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

• (a) the quality system documentation;

• (b) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.

4.3. The notified body shall carry out periodic audits, at least once a year, 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 examinations or tests of the PPE, 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.

5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latters identification number to each individual item of PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.

5.2. The manufacturer shall draw up a written EU declaration of conformity for each PPE model and keep it at the disposal of the national authorities for 10 years after the PPE has been placed on the market. The EU declaration of conformity shall identify the PPE model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

• (a) the documentation referred to in point 3.1;

• (b) the information related 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.

The 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 such quality system approvals which it has issued.

The manufacturers 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.

Regulation 15

SCHEDULE 9 Text of Annex IX to the PPE Regulation

EU DECLARATION OF CONFORMITY No….⁶

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

Regulation 2

SCHEDULE 10 Text of Annex X to the PPE Regulation

CORRELATION TABLE

Directive 89/686/EEC	This Regulation
Article 1(1)	Articles 1 and 2(1)
Article 1(2) and (3)	Article 3 point (1)
Article 1(4)	Article 2(2)
Article 2(1)	Article 4
Article 2(2)	Article 6
Article 2(3)	Article 7(2)
Article 3	Article 5
Article 4(1)	Article 7(1)
Article 4(2)	—
Article 5(1), (4), (5)	—
Article 5(2)	Article 14
Article 6	Article 44
Article 7	Articles 37-41
Article 8(1)	Article 8(2) first subparagraph
Article 8(2)-(4)	Articles 18 and 19 and Annex I
Article 9	Articles 20, 24(1), 25, and 30(1)
Article 10	Annex V
Article 11(A)	Annex VII
Article 11(B)	Annex VIII
Article 12(1)	Article 15
Articles 12(2) and 13	Articles 16 and 17
Article 14	—
Article 15	—
Article 16(1) first subparagraph and (2)	—
Article 16(1) second subparagraph	Article 48(2)
Annex I	Article 2(2)
Annex II	Annex II
Annex III	Annex III
Annex IV	Article 16
Annex V	Article 24(2)-(11)
Annex VI	Annex IX

Given under my Official Seal

19 April 2018.

HEATHER HUMPHREYS,

Minister for Business, Enterprise and Innovation.

EXPLANATORY NOTE

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

The Regulations transpose into national legislation the provisions of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC. These Regulations also set out the obligations on economic operators in relation to these products and the required conformity assessment procedures for PPE. These Regulations also give further effect 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.

The Regulations provide that the making available on the market of PPE in conformity with Directive 89/686/EEC continues to be lawful up to 21 April 2019.

The Regulations revoke and replace the European Communities (Personal Protective Equipment) Regulations, 1993 ( S.I. No. 272 of 1993 ), the European Communities (Personal Protective Equipment) (Amendment) Regulations, 1994. ( S.I. No. 13 of 1994 ), the European Communities (Personal Protective Equipment) (CE Marking) Regulations, 1994 ( S.I. No. 457 of 1994 ) and the European Communities (Personal Protective Equipment) (Amendment) Regulations, 1997 ( S.I. No. 81 of 1997 ) cited together as the European Communities (Personal Protective Equipment) Regulations 1993 to 1997, from 21 April 2018.

Footnotes