Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1)

[LMU23]

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.

[Wes Bucey]

Welcome to the Cove

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[wrodnigg]

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.

[c1991209384]

Our notified body has the requirement that the clinical data must be reviewed by a qualified personnel, e.g a doctor.

[Al Rosen]

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.

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.

[c1991209384]

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

Thank you in advance.

[Al Rosen]

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.

[gdwaikle]

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.