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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 :EMEA Revised Q and A document .. 2009-09-01 21:57:52 
GCP HelpDesk
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EMEA have revised the Q&A document in chapter V of Eudralex Vol 10.

The changes are:

New Question 3: Clarifies that a commercially available product used as a comparator in a clinical trial is considered to be IMP.

New question 4: Defines a non-interventional trial to clarify that these are not subject to GCP.

Revised question 8: Clarifies that the sponsor can delegate duties/tasks but remains RESPONSIBLE for the clinical trial.

Revised question 18: Annual safety reports can be aligned with PSURs and/or IND Annual Reports provided this results in a shortened reporting time and not a lengthened one.
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