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2. Documentation
The mandatory documentation includes the instruction manual (section 2.1 ) and the technical file (section 2.2 ).
2.1 Instruction manual
Annex I sets out the requirements for the instruction manual. Very simply,...
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The Ultimate Scientific and Technical Reference
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Bibliography
Bibliography
Regulations
Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, known as the Toys Directive
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Directive 2006/42/EC of the European Parliament and of the Council on machinery, and amending Directive 95/16/EC
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