R
Hi,
We are preparing the Technical File for the 12 Lead ECG Monitor.
Should we have to submit the Clinical Report, If yes can any guide us how, if No...how to submit?
In FDA if we follow the Guidance for Industry - Diagnostic ECG Guidance (EC 11) standard - its is enough, there is no need to submit the Clinical Reports.
Will the same can be followed for CE Marking procedures also....I tried to look at the MDD Directives but i couldn't find any information!
Can any one please help us!
We are preparing the Technical File for the 12 Lead ECG Monitor.
Should we have to submit the Clinical Report, If yes can any guide us how, if No...how to submit?
In FDA if we follow the Guidance for Industry - Diagnostic ECG Guidance (EC 11) standard - its is enough, there is no need to submit the Clinical Reports.
Will the same can be followed for CE Marking procedures also....I tried to look at the MDD Directives but i couldn't find any information!
Can any one please help us!