Directive 2011/65/EU
第9条 輸入業者の義務
Article 9 — Obligations of importers
加盟国は、次のことを確保しなければならない。
Member States shall ensure that:
(a)importers place only EEE that complies with this Directive on the Union market;
(b)輸入業者が、EEEを上市する前に、製造業者により適切な適合性評価手続が実施されたことを確保し、さらに、製造業者が技術文書を作成したこと、EEEにCEマーキングが付され、必要な文書が添付されていること、及び製造業者が第7条(f)及び(g)に定める要件を遵守したことを確保すること
(b)importers, before placing an EEE on the market, ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer, and that they further ensure that the manufacturer has drawn up the technical documentation, that the EEE bears the CE marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in points (f) and (g) of Article 7;
(c)where an importer considers or has reason to believe that an EEE is not in conformity with Article 4, that importer does not place the EEE on the market until it has been brought into conformity, and that that importer informs the manufacturer and the market surveillance authorities to that effect;
(d)輸入業者が、自らの名称、登録商号又は登録商標及び連絡先住所をEEEに、又はそれが不可能な場合にはその包装若しくはEEEに添付される文書に表示すること。その他の適用される連合法令に輸入業者の名称及び住所の表示に関する少なくとも同等に厳格な規定がある場合には、当該規定が適用される。
(d)importers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE. Where other applicable Union legislation contains provisions for the affixing of the importer’s name and address which are at least as stringent, those provisions shall apply;
(e)輸入業者が、本指令への適合を確保するため、不適合EEE及びEEEのリコールの記録簿を保持し、流通業者にその情報を提供すること
(e)importers, in order to ensure compliance with this Directive, keep a register of non-compliant EEE and EEE recalls, and keep distributors informed thereof;
(f)自らが上市したEEEが本指令に適合していないと考え、又はそう信じる理由がある輸入業者が、当該EEEを適合させ、撤去し、又は適切な場合にはリコールするために必要な是正措置を直ちにとり、自らがEEEを提供した加盟国の管轄国家当局に、特に不適合及びとった是正措置の詳細を示して、直ちにその旨を通知すること
(f)importers who consider or have reason to believe that an EEE which they have placed on the market is not in conformity with this Directive immediately take the corrective measures necessary to bring that EEE into conformity, to withdraw it or recall it, as appropriate, and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;
(g)輸入業者が、EEEの上市後10年間、EU適合宣言の写しを市場監視当局が利用できるよう保持し、要請に応じて技術文書を当該当局が利用できるようにすることを確保すること
(g)importers keep, for 10 years following the placing on the market of the EEE, a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request;
(h)輸入業者が、管轄国家当局からの理由を付した要請に応じて、EEEの本指令への適合を証明するために必要なすべての情報及び文書を、当該当局が容易に理解できる言語で当該当局に提供し、自らが上市したEEEの本指令への適合を確保するためにとられるあらゆる措置について、当該当局の要請に応じて協力すること
(h)importers, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EEE with this Directive in a language which can be easily understood by that authority, and that they cooperate with that authority, at its request, on any action taken to ensure compliance with this Directive of EEE which they have placed on the market.