Transcription of In Vitro Diagnostic Performance Evaluation Studies: …
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In Vitro Diagnostic Performance Evaluation Studies: …
14 | April 2011 European medical Device Technology e g u l a t i o n s a n d s t a n d a r d sEuropean definitions and implicationsArticle 1(e) of the European In Vitro Diagnostic medical devices Directive (IVDD; 98/79/EC) defines a device for Performance Evaluation as any device intended by the manufacturer to be sub-ject to one or more Performance Evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises. The term Performance Evaluation is not defined in the IVDD; however, it is defined in the European harmonised standard, EN 13612:2002, Performance Evaluation of in Vitro Diagnostic medical devices .
emdt.co.uk European Medical Device Technology April 2011 | 17 required retention time, which is at least five years after the end of the performance evaluation. ...
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