Guide to application of the ATEX 2014/34/UE directive - ANNEX III MODULE B: EU-TYPE EXAMINATION

ANNEX III

MODULE B: EU-TYPE EXAMINATION

1.           EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of this Directive that apply to it.

2.           EU-type examination shall be carried out with the examination of a specimen, representative of the production envisaged, of the complete product (production type).

§ 178  EU-type examination

EU-type examination provides a specimen of the envisaged production to a notified body which undertakes the necessary evaluation to determine that the “type” meets the essential requirements of Directive 2014/34/EU and issues an EU-type examination certificate. As an additional result of EU-type examination a list of schedule documentation is precise.

EU-type examination is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated (see also section § 89 on conformity assessment procedures and Table 3).

3.           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. The technical documentation shall make it possible to assess the product's conformity with the applicable requirements of this Directive 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:

                        (i)        a general description of the product,

                        (ii)       conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

                        (iii)      descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

                        (iv)      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 this 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,

                        (v)       results of design calculations made, examinations carried out, etc., and

                        (vi)      test reports,

              (d)     the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme.

§ 179  The application for EU-type examination

In order to make the application process easier, notified bodies have prepared specific application forms. After a verification of the application form and after checking that the submitted documents and testing sample or samples are suitable to carry out the certification process, the concerned notified body issues a written confirmation of receipt of the application from the manufacturer.

The required tests, carried out by the notified body, may need a special preparation of testing sample or samples. It is agreed between applicant and notified body, within their own contractual agreements.

The notified body takes full responsibility on the scope of tests and assessments.

4.           The notified body shall:

4.1.        examine the technical documentation, 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 relevant technical specifications;

4.2.        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;

4.3.        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 applying other relevant technical specifications meet the corresponding essential health and safety requirements of this Directive;

4.4.        agree with the manufacturer on a location where the examinations and tests will be carried out.

§ 180  Tasks to be performed by the notified body

The notified body has to carry out the examination of the technical documentation as well as of the sample or samples. In particular:

- carries out appropriate examinations and tests,

- draws up an evaluation report that may be released only upon agreement with the manufacturer,

- issues an EU-type examination certificate,

- informs its notifying authorities and the other bodies about the EU-type examinations it has performed, and

- keeps record of its decisions and other relevant information.

5.           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.

§ 181  The evaluation report

The results of the assessment and tests carried out by the notified body have to be included in an ATEX Assessment Report.

See section § 112 on the minimum content of a European standardised ATEX test and assessment report.

6.           Where the type meets the requirements of this Directive that apply to the product concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached.

              The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

              Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

§ 182  The EU-type examination certificate

The European ATEX Notified Bodies Group (ExNBG) has established a format for the EU-type examination certificate. The EU-type examination certificate may contain a special condition of use for equipment or protective system or schedule of limitation for component.

The EU-type examination certificate has to contain all the information necessary for the identification of the product:

  • identification number of certificate;
  • name and type of product;
  • manufacturer’s name and address;
  • list of harmonized standards used for assessment (if any);
  • description of product;
  • list of technical parameters significant for Ex safety;
  • schedule of limitation or special condition of use.

EU-type examination certificates may indicate an end of validity date, even this is not explicitly required by the ATEX Directive 2014/34/EU (see section § 186).

§ 183  The EU-type examination certificate and the responsibilities of stakeholders

An EU-type examination certificate attests that a specimen (including instructions, as appropriate) representative of the production envisaged by the manufacturer fulfils the relevant applicable provisions of the Directive, in particular the essential health and safety requirements (EHSRs). The question arises as to the actions that need to be taken when the "generally acknowledged state of the art" has developed. It is clear that the original specifications applied may continue to show fulfilment of the EHSRs and the EU-type examination certificate then remains valid.

However, over time the "generally acknowledged state of the art" can develop substantively such that the specifications originally applied no longer ensure the type examined complies with the EHSRs. It should be noted that the question of whether there has been substantive development of the state of the art is not left to discretionary interpretation by the notified body, but has equally to be generally acknowledged by the technical community of the stakeholders. The publication of a revised European harmonised standard would be one way to recognise a development in the state of the art: in this case, the responsible European Standardisation Organisation (ESOs: CEN, CENELEC) shall determine whether the state of the art concerning the EHSRs has changed, and if so, in what respects. The ESO shall indicate this in the foreword of each standard.

In such cases, if the specifications and evaluation criteria originally applied to a product no longer ensure that it complies with the latest state of the art, the EU-type examination certificate is no longer valid and further action is required. Given reasonable transition periods and knowledge of current developments, it is expected that the manufacturer will have sufficient time to contact a notified body to undertake the necessary re-evaluation so that there is a smooth transition from one set of applied specifications to another. Notified bodies, who are expected to maintain a good knowledge of developments in the state of the art, should make arrangements to alert the holders of their EU-type examination certificates to the revision of harmonised standards.

It should be noted, however, that the issuing of a new EU-type examination certificate will have no retroactive effect and, therefore, will not affect products placed on the market and/or put into service whilst the manufacturer was in possession, where appropriate, of a valid certificate.

It should also be re-affirmed that the overall responsibility for compliance of the product rests with the manufacturer who, where required, must ensure that a valid certificate is in his possession, as well as that all relevant conformity documents correspond to the current state of the art. In parallel, the notified body must provide all the relevant information for the manufacturer in order to ensure that the existing certificate is correct in its evaluation that the type continues to meet the EHSRs.

7.           The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

              The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential health and safety requirements of this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

§ 184  Changes and modifications

Any changes concerning the EU-type examination certificate must be indicated in a specific supplement to the original certificate.

Changes may be a result of:

  • technical parameters changes;
  • name or type changes;
  • new version of the product;
  • conditions of product use changes;
  • harmonised standards changes.

The form of addition to EU-type examination certificate is also established by the European ATEX Notified Bodies Group (ExNBG).

The way how manufacturers inform about these changes should be agreed: by website, mailing, audit, etc.

8.           Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

              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 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, until the expiry of the validity of that certificate.

§ 185  Obligations for the notified body

Notified bodies are obliged to co-operate and coordinate their activities. In particular, notified bodies have a general obligation to inform the other notified bodies and national market surveillance authorities about all certificates suspended or withdrawn due to safety related nonconformities and, on request, about certificates issued or refused (see also section § 115).

Notified bodies must also provide market surveillance authorities with relevant information for the purpose of market surveillance; even if is considered inappropriate for notified bodies to be responsible for market surveillance activities as such.

§ 186  Validity of EU-type examination certificates

Paragraphs 6, 7 and 8 of Annex III to the ATEX Directive 2014/34/EU include some references to the validity of EU-type examination certificates. Such references come from the Decision No 768/2008/EC of the New Legislative Framework, used to align and recast the previous Directive 94/9/EC.

In this sense, there is not a clear obligation on establishing a period of validity for EU-type examination certificates; in principle, certificates remain valid until their expiry date, when indicated. Nevertheless, the tendency supported by the Commission goes towards a limitation of validity of certificates to 5 years, in a similar way as established in the Machinery Directive 2006/42/EC, Annex IX, point 9.3.

9.           The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

§ 187  Obligations for the manufacturer

The provision on “10 years after the product has been placed on the market” should be understood as related to the last item of the product model placed on the market.

After such 10 (ten) years period, the manufacturer ceases to be liable, unless legal action is pending. Further, any prejudiced party (the victim of damages) must file an action within three years of the damage, the defect and the identity of the producer being known. No waivers of liability in relation to the injured person may be agreed.

The Directive on product liability[1] does not require Member States to repeal any other legislation on liability. In this respect, the Directive’s regime adds to the existing national rules on liability. It is up to the victim to choose the grounds on which to file the action.

10.         The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

§ 188  Authorised representative

According to the mandate contractually agreed with the manufacturer, the authorised representative can be entitled to lodge the application for the EU-type examination and to fulfil the obligations related to information on modifications, and to retaining a copy of the EU-type examination certificate.

 

[1] Council Directive of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (85/374/EEC) (OJ L 210, 7.8.1985, p. 29)