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Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7

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Document information
Reference GBR Directive 93/42/EEC 11-Oct-2007
Validity area GBR
Scope(s) MD
Document name Directive 93/42/EEC
Version / Revision 11-Oct-2007
Status Current
Document type Legal act
Language(s) EN
Description COUNCIL DIRECTIVE 93/42/EEC - of 14 June 1993

concerning medical devices

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 6 — Unit 6.4.2
Scope MD
Document part Annex X

2.3.7

Language EN
Original entry by Florian Adragna
Contributors
Tags Clinical study report, Clinical investigation, Signature, Requirements

Content

2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation.