EU Medical Device Regulation 2017/745. Reformatted.

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EU Medical Device Regulation 2017/745. Reformatted.

Abstract Essence

[the] [of] [and] [to] [in] [shall] [or] [a] [be] [for] [Article] [with] [that] [device] [by] [devices] [as] [The] [on] [is] [notified] [clinical] [referred] [body] [which] [assessment] [manufacturer] [are] [this] [Member] [its] [any] [conformity] [information] [accordance] [Annex] [an] [Regulation] [other] [1] [intended] [not] [where] [investigation] [system] [safety] [Commission] [market] [requirements] [such] [from] [their] [use] [relevant] [may] [out] [it] [paragraph] [2] [documentation] [have] [competent] [authority] [has] [3] [bodies] [if] [State] [including] [UDI] [Section] [4] [applicable] [class] [evaluation] [they] [means] [appropriate] [data] [performance] [States] [into] [procedures] [available] [at] [been] [s] [all] [technical] [up] [management] [those] [procedure] [application] [activities] [risk] [ensure] [set] [used] [case]