The manufacturer's obligations
Both, Producer and or the producer's appointed "European Authorized Representative" and the distributors of the producer's products should help in ensuring compliance with the applicable safety requirements. (§ 20).
Within the limits of the manufacturer and the distributor respective activities, they shall provide consumers with:
Relevant information to consumers: Relevant information to enable consumers to assess the risks inherent in the product throughout the normal or reasonably foreseeable period of its use.(Article 5.1)
Information of risks Information to consumers of risks which the product might pose; (Article 5 {a}).
Appropriate action Choose to take appropriate action including, if necessary to avoid these risks, withdrawal from the market, adequately and effectively warning consumers or recall from consumers. (Article 5{b}).
The measures referred to in the above 3 paragraphs shall include:
A) An indication, by means of the product or its packaging, of the identity and details of the producer, his "European Authorized Representative", and the product reference or, where applicable, the batch of products to which it belongs, except where not to give such indication is justified and (Article 5.1 {a}).
B) In all cases where appropriate, the carrying out of sample testing of marketed products, investigating and, if necessary, keeping a register of complaints and keeping distributors informed of such monitoring. (Article 5.1 {b}).
Such action shell be undertaken on a voluntary basis or at the request of the European Competent Authorities in accordance with Article 8(1)(lf).
Informing the European Competent Authorities Where producer and distributor know or ought to know, on the basis of the information in their possession and as professionals, that the product they have placed on the market poses risks to the consumer that are incompatible with the general safety requirement, they shell immediately inform the European competent authorities under the conditions laid down in Annex I giving details, in particular, of action taken to prevent risk to the consumer.(article 5.3).
Cooperate with the European Competent Authorities Producers through his "European Authorized representative" and distributors shall, within the limits of their respective activities, cooperate with the European competent Authorities at the request of the latter, on action taken to avoid the risks posed by products which they supply or have supplied. The procedures for such cooperation, including procedures for dialogue with the producers and distributors on issues related to the products safety, shall be established by the competent authorities. (Article 5.4).
Obelis European Authorized Representative Advisory Notice
Appoint Obelis European Authorized Representative Center (O.E.A.R.C.) as your "European Authorized Representative" within the EU.
Obelis European Authorized Representative determines the applicable Standards - European, International or National.
Identify the appropriate conformity assessment module according to your product classification.
To implement a full "Quality system " that include:
a) Post-Market Surveillance system. (Article 5.1)
b) Vigilance & Trace ability system. (Article 5)
c) Risk analysis report. (Article 5)
d) Safety assessment report.
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