ATEX certification for non-original manufacturers

ATEX certification for the manufacturers which are not original manufacturer of explosion proof product

Definitions

Manufacturer A (original manufacturer): produces and sells equipment for which he holds an EU-type examination certificate issued in his own name.
Manufacturer B: a second manufacturer whose acting as a trade agent of manufacturer A (the original manufacturer) and applies for an EU-type examination certificate in his name, based on the certificate previously granted to A by a notified body NB.

Obligations for manufacturer A

the quality management system related to the product in question, must be approved, according to directive 2014/34/EU by a notified body NB1;

Note: the scope of QAN for manufacturer A must clearly include the product subject to trading between A and B.

submission the EU type examination certificate for the product to the manufacturer B;

Obligations for manufacturer B

the quality management system related to the product in question, must be approved, according to directive 2014/34/EU by a notified body NB2 and accordingly a QAN should be issued;
if the manufacturer B chooses to have the equipment manufactured under subcontract, he must ensure that the quality system used by the sub-contractor is in compliance with the relevant requirements of directive 2014/34/EU, therefore the quality management system of the subcontractor related to the product in question, must be approved, according to directive 2014/34/EU by a notified body NB2.
On receipt of the new EU type examination certificate, the manufacturer B is authorized to issue his own EU declaration of conformity, affixes the CE-mark with the identification number of the notified body NB2 and sells the equipment in his own name on the EU market.
Since the procedure for issuing a second EU-type examination certificate in a second (B) manufacturer’s name, is not explicitly covered by ATEX directive 2014/34/EU, it would appear justifiable in order to support established commercial practices, e.g.manufacturing or selling under licence, therefore there should be an appropriate commercial agreement between manufacturer A and B, covering the requirements of this article.
the manufacturer B should collaborate with manufacturer A for inspection of B's labelled product during surveillance assessments by the NB relevant to the QAN of manufacturer A, as well as sharing necessary documents of his quality assurance system with manufacturer A.

Required documents for the notified body

the original or a copy of the issued EU-type examination certificate by notified body in the name of manufacturer A (original manufacturer);
a declaration by the original manufacturer (A) that the equipment to be produced under the name of the second manufacturer or trade agent (B), will be identical with the originally certified equipment,
a declaration by the second manufacturer or trade agent (B) that the equipment brought to the EU market will be identical to that originally certified, and
the original or a copy of the contractual agreement between A and B.

Process and requirements for certification

evaluation and certification for the B is performed on the basis of the initial EU type examination certificate and relevant report that already issued for A;
assessing quality assurance system of B is performed by a notified body (NB2) and the QAN will be issued for B;
since B does not physically produce the ATEX product himself (i.e it is a trade agent of A), a full assessment against Annex IV or VII cannot be achieved, unless the compliance of manufacturer A’s quality assurance system, as the actual producer of B’s product, has been established and the following points could be ensured:
- in assssing quality assurance system of B by NB2, the processes could be followed-back to the assessment of the product of original manufacturer by NB1;
- a combined quality assurance system of the manufacturers A and B, covered by valid QANs for both A and B is necessary, based on annex IV or VII of ATEX directive, could be demonstarted and in this regard.

Note: manufacturer B must prepare a quality management system documentation based on EN ISO/IEC 80079-34 covering production phase which is performed by manufacturer A, supplying and controlling phases of the product which is performed by himself (B).

an appropriate quality assurance system should exist for the products identified in EUtype examination certificate, so that notified body NB2 can issue its own QAN to the B, and permit the use of its NB2 number adjacent to the CE-mark on the label of the B's product.

assessment result and the certificates (EU type examination and QAN) to be granted to the manufacturer B, must be informed by NB2 to the notified body whose already granted the certificates to the manufacturer A.
the clients of the manufacturer B or the market place, in principle, has no knowledge of the relationship between B and A, and, under the ATEX Directive, B is considered as the "manufacturer" and has fulfilled all the necessary requirements for a manufacturer.

Relation and traceability between issued certificates

a visible traceability of the QAN held by B to the QAN issued to manufacturer A, should be kept. e.g. by referring in quality assurance system documentation of B;
a referral to the EU type examination certificate issued for the manufacturer A must be included in the QAN which has been issued for A;
since the NB whose assess quality assurance system of the A, may be unaware of the assessment and granting QAN to B because it may be conducted through a different notified body (NB2), the labelled version of the manufacturer's B product, should be examined by the original product manufacturer's notified body (NB1) during the course of surveillance assessments of manufacturer A.
when B is provided with an EU-type examination certificate, the QAN already granted to the manufacturer A (relevant to the product subject to trading between A and B) and the existing QAN for B (IF EXIST, relevant to the other products not subject to trading between A and B) should be updated to identify the products covered by B's EU type examination certificate within the schedules.

ATEX certification for non-original manufacturers

ATEX certification for non-original manufacturers

ATEX certification for the manufacturers which are not original manufacturer of explosion proof product

Definitions

Manufacturer A (original manufacturer): produces and sells equipment for which he holds an EU-type examination certificate issued in his own name.

Manufacturer B: a second manufacturer whose acting as a trade agent of manufacturer A (the original manufacturer) and applies for an EU-type examination certificate in his name, based on the certificate previously granted to A by a notified body NB.

Obligations for manufacturer A

the quality management system related to the product in question, must be approved, according to directive 2014/34/EU by a notified body NB1;

Note: the scope of QAN for manufacturer A must clearly include the product subject to trading between A and B.

submission the EU type examination certificate for the product to the manufacturer B;

Obligations for manufacturer B

the quality management system related to the product in question, must be approved, according to directive 2014/34/EU by a notified body NB2 and accordingly a QAN should be issued;

On receipt of the new EU type examination certificate, the manufacturer B is authorized to issue his own EU declaration of conformity, affixes the CE-mark with the identification number of the notified body NB2 and sells the equipment in his own name on the EU market.

the manufacturer B should collaborate with manufacturer A for inspection of B's labelled product during surveillance assessments by the NB relevant to the QAN of manufacturer A, as well as sharing necessary documents of his quality assurance system with manufacturer A.

Required documents for the notified body

the original or a copy of the issued EU-type examination certificate by notified body in the name of manufacturer A (original manufacturer);

a declaration by the original manufacturer (A) that the equipment to be produced under the name of the second manufacturer or trade agent (B), will be identical with the originally certified equipment,

a declaration by the second manufacturer or trade agent (B) that the equipment brought to the EU market will be identical to that originally certified, and

the original or a copy of the contractual agreement between A and B.

Process and requirements for certification

evaluation and certification for the B is performed on the basis of the initial EU type examination certificate and relevant report that already issued for A;

assessing quality assurance system of B is performed by a notified body (NB2) and the QAN will be issued for B;

in assssing quality assurance system of B by NB2, the processes could be followed-back to the assessment of the product of original manufacturer by NB1;

a combined quality assurance system of the manufacturers A and B, covered by valid QANs for both A and B is necessary, based on annex IV or VII of ATEX directive, could be demonstarted and in this regard.

Note: manufacturer B must prepare a quality management system documentation based on EN ISO/IEC 80079-34 covering production phase which is performed by manufacturer A, supplying and controlling phases of the product which is performed by himself (B).

an appropriate quality assurance system should exist for the products identified in EUtype examination certificate, so that notified body NB2 can issue its own QAN to the B, and permit the use of its NB2 number adjacent to the CE-mark on the label of the B's product.

assessment result and the certificates (EU type examination and QAN) to be granted to the manufacturer B, must be informed by NB2 to the notified body whose already granted the certificates to the manufacturer A.

the clients of the manufacturer B or the market place, in principle, has no knowledge of the relationship between B and A, and, under the ATEX Directive, B is considered as the "manufacturer" and has fulfilled all the necessary requirements for a manufacturer.

Relation and traceability between issued certificates

a visible traceability of the QAN held by B to the QAN issued to manufacturer A, should be kept. e.g. by referring in quality assurance system documentation of B;

a referral to the EU type examination certificate issued for the manufacturer A must be included in the QAN which has been issued for A;