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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :Major developments in EU Clinical Trial Guidances.. 2010-04-21 03:13:23 
GCP HelpDesk
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Dear Friends,

Please find the major developments in clinical trials in Europe.

30/03/2010 :Summary of the Responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC". This document summarises the responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"

Revision of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (Version of March 2010). This Document is available in Volume 10 of EudraLex.

Guidance documents applying to clinical trials - Questions & Answers Document, Version 5.0 (March 2010). The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. This document is available in Volume 10 of EudraLex.

Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents (March 2010).

Kind regards,
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Last Edited On: 2010-04-21 03:13:23 By GCP HelpDesk for the Reason
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