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Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
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4.GENERAL SAFETY AND PERFORMANCE REQUIREMENTSU.K.
The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:
(a)
the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
(b)
the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;
(c)
the harmonised standards, CS or other solutions applied; and
(d)
the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.
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