Tekst polski MEDDEV 2.7/3, z grudnia 2010 r.
Thread poster: Tomasz Poplawski

Tomasz Poplawski  Identity Verified
Local time: 23:40
Member (2007)
English to Polish
+ ...
May 24, 2012

Wszystkie oczywiste źródła przeszukałem, bez skutku.
Chodzi mi konkretnie o brzmienie po polsku następującego fragmentu:

“The reporting modalities and format set out in this guidance apply to pre-market3 clinical
investigations4-5 conducted with:
a. Non-CE marked devices,
b. CE marked devices used outside the intended use(s) covered by the CE marking.
The tabular format featured in the Appendix needs to be updated for each reportable
event or for new findings/updates to already reported events. It shall be transmitted to all
NCAs where the clinical investigation is being performed.

5 Where the right to bear the CE marking has been obtained before the end of the clinical investigation, the SAE reporting continues until completion of the investigation, according to the clinical investigation plan.”

Z góry dzięki za pomoc


 


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Tekst polski MEDDEV 2.7/3, z grudnia 2010 r.

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