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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 :New EMEA guideline on Co-ordination of Inspections .. 2009-09-01 22:00:39 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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EMEA has produced another new guideline on inspections covering co-ordination between member states of inspections to verify GCP compliance of Marketing Authorisation Applications under the Mutual Recognition or Decentralised procedures.  It doesn't cover inspections for the Centralised Procedure or routine national inspection procedures.  There has also been a revision to the guideline on exchange of inspection reports. For details click here.
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Last Edited On: 2009-09-01 22:00:39 By GCP HelpDesk for the Reason
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