Source: http://www.industry-finder.com/machinery-directive/guide-application-atex-2014-34-ue-directive-annex-iii-module-b-eu-type
Timestamp: 2018-10-20 20:27:34
Document Index: 697032678

Matched Legal Cases: ['§ 178', '§ 89', '§ 179', '§ 180', '§ 181', '§ 112', '§ 182', '§ 186', '§ 184', '§ 185', '§ 115', '§ 187', '§ 188']

Guide to application of the ATEX 2014/34/UE directive - ANNEX III MODULE B: EU-TYPE EXAMINATION | Machinery directive 2006/42/CE - Functional safety & ATEX directive 2014/34/EU
Submitted by root on Fri, 04/15/2016 - 00:25
§ 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).
(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:
§ 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.
§ 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.
§ 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.
§ 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;
list of harmonized standards used for assessment (if any);
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).
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.
§ 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.
§ 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.
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.
§ 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.
§ 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)
Saturday 20th of October 2018 10:27:34 PM PW