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annex
(redirected from annexes)

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Directive 2007/47/EC now also permits manufacturers to use Annex II (Recital 11) to obtain CE marking for Class I measuring and sterile devices, in addition to the previous annexes (IV, V and VI) available.
PCCA STD-101 establishes conventions for uniform extension of its own scope and content through Annexes.
Along with the annexes, another valuable reference for guidance on developing a clinical evaluation report is the European Commission's guidance document MEDDEV 2.
 
 
 
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