F1ANNEX IICONFORMITY ASSESSMENT PROCEDURES
F1Module EConformity to type based on product quality assurance
F11.
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F12.Manufacturing
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F13.
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F13.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.
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F13.2.The quality system shall ensure compliance of the products with the type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument.
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F13.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
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F13.4.
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F13.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
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F14.
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F14.1.
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F14.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
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F14.3.
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F14.4.
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F15.
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F15.1.
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F15.2.The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.
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F16.The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:
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F17.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.
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F18.Authorised representative
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Decision revoked (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), Sch. 2 Pt. 2 (with reg. 29(2)) (as amended by S.I. 2020/1376, regs. 1(4), 3(20)); 2020 c. 1, Sch. 5 para. 1(1); and also expressed to be revoked (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), Sch. 37 para. 1(c) (as amended by S.I. 2020/676, regs. 1(1), 3); 2020 c. 1, Sch. 5 para. 1(1)