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meddev - ec guidelines on medical devices, clinical trials and studies and investigations
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  #1  
Old 28th January 2005, 01:23 PM
LMU23 LMU23 is offline
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Please Help! Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1)

I am working on creating a procedure for clinical data evaluation based on the MEDDEV guidance (MEDDEV 2.7.1) using the literature route. If anyone is able to point me in the direction of an example procedure or an example of a clinical data report it would be very helpful.

I'd also appreciate any other input on the topic. Thank you.

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Old 28th January 2005, 01:32 PM
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Welcome to the Cove

Congratulations on making your first post!

I'm sure some of our experts may have just the ticket for you. Be patient - it may take a day or more to get some significant responses.
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Old 2nd February 2005, 06:42 AM
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Hello LMU23,

just begin to write a procedure which describes the tasks written down in MEDDEV 2.7.1.

The output from the "literature route" should be a collection of scientific literature according to the intended use of the medical device (including a description of required techniques...) and some kind of final report (containing pros and cons).

That's it.
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Old 14th September 2005, 05:46 AM
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personnel qualification for reviewing the clinical data

Our notified body has the requirement that the clinical data must be reviewed by a qualified personnel, e.g a doctor.
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Old 14th September 2005, 12:44 PM
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Quote:
In Reply to Parent Post by c1991209384

Our notified body has the requirement that the clinical data must be reviewed by a qualified personnel, e.g a doctor.
FRom the guidance, MEDDEV 2.7.1.
Quote:
3. Literature route

Due regard needs to be paid to the extent to which the published data are relevant and applicable to the relevant characteristics of the device under assessment and the medical procedure for which the device is intended.

A literature review should be performed by person(s) suitably qualified in the relevant field, knowledgeable in the “state of the art” and able to demonstrate objectivity.
It doesn't specifically state doctor so I think it can be done by a person other than a doctor as long as he is suitably qualified in the relevant field, knowledgeable in the “state of the art” and able to demonstrate objectivity.
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Thanks to Al Rosen for your informative Post and/or Attachment!
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Old 14th September 2005, 08:24 PM
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Question to the native English speakers

What did you mean " state of the art" ? In what context can this phrase be used ?

Thank you in advance.
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Old 14th September 2005, 09:29 PM
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In Reply to Parent Post by c1991209384

What did you mean " state of the art" ? In what context can this phrase be used ?

Thank you in advance.
"State of the Art" means very up to date or most recent level of technology.
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  #8  
Old 15th September 2005, 04:53 PM
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Al is exactly correct. I was a lead auditor for a Notified Body and thought as you did that the literature review needed to be by a doctor. One of my clients challanged me on that and I began to investigate through our Notified Body overseas. I found out as Al states the review needs to be made by someone who is suitably qualified in the relevant field, knowledgeable in the “state of the art” and able to demonstrate objectivity. What that means is you may be asked and should offer to supply a CV for that reviewer to justify that they are in fact qualified to perform the duties for the review. This will avoid questions by the Notified Body and also avoid delay's in the review process.
Thanks to gdwaikle for your informative Post and/or Attachment!
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