Clinical Evidence and Expert Evaluation - Guidance Notes (MEDDEV 2.7.1)

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s.parakos

I am just trying to confirm whether I am correctly comprehending the guidance notes (MEDDEV 2.7.1) on Evaluation of Clinical Data.

As I read it, we, the manufacturer, compile supporting data, in our case through a literature review. This literature review is then evaluated by a clinical expert who writes a report confirming it's validity. Does that sound correct?

Does anybody have a template or example of a literature review and/or expert report?

thanks
Simon
 

Marcelo

Inactive Registered Visitor
Re: Clinical Evidence and Expert Evaluation

Generally speaking , you´re correct. But you should follow the complete guidelines on 4.3, 4.3.1 and 4.3.2. Also, as mentioned in 4.2 you must input your findings, specially the ones related to safety, in your risk management process, and define (if needed) risk controls for the risks deemed unnaceptable by your risk acceptability criteria. This means that you not only have to review the clinical data and confirm its validity, you also have to use this as an input in your device development lifecycle.
 
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s.parakos

Re: Clinical Evidence and Expert Evaluation

Thanks for your reply.

Generally speaking , you´re correct. But you should follow the complete guidelines on 4.3, 4.3.1 and 4.3.2. Also, as mentioned in 4.2 you must input your findings, specially the ones related to safety, in your risk management process, and define (if needed) risk controls for the risks deemed unnaceptable by your risk acceptability criteria. This means that you not only have to review the clinical data and confirm it´s validity, you also have to use this as an input in your device development lifecycle.

From the guidelines it is not quite clear to me which parts we (the manufacturer) must do and which parts we ask a clinical expert to perform. I was hoping we could do all the data gathering, analysis and evaluation, and have a suitably qualified impartial expert sign off on it.

SImon
 

Marcelo

Inactive Registered Visitor
Re: Clinical Evidence and Expert Evaluation

From the guidelines it is not quite clear to me which parts we (the manufacturer) must do and which parts we ask a clinical expert to perform. I was hoping we could do all the data gathering, analysis and evaluation, and have a suitably qualified impartial expert sign off on it.

This seems ok to me, as long as the manufacturer has qualified personnel to perform the data gathering, analysis and evaluation. Bear in mind that this is not a trivial process, and in fact for some types of devices (depending on the interaction with the patient and thus the ammount of clincal data involved) it seems to me that the best route would be to use and external expert to perform the whole process (although this could raise some concerns in relation to the ability of the manufacturer to design and keep the safety of the device - as i mentioned before, i cannot see the evaluation of clinical data as a separate procedure from the development and other life cycle processes).

It´s also interesting to bear in mind one point that i always try to stress (and strangely enough a lot of people don´t get it, simply because they rely too much on rules, regulations, standards and the like): as the manufacturer, you are the expert and thus the main responsable for your device. So, you have to apply all the controls you see fit (and the regulations, as they are now mainly based on risk management and essential principles aspects rather than detailed technical specifications, permit this) as long as you deemed them as acceptable (and, as there´s generally a third party inspection involved, you can demonstrate for them that your approach is reasonably sound).
 
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azaplas

Re: Clinical Evidence and Expert Evaluation

This is just a general question for anyone on the boards. About how many pages did your clinical evaluation / clinical trials document come out to be? I'm trying to see if I'm on the right track. Thanks!
 
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SteveK

Re: Clinical Evidence and Expert Evaluation

This is just a general question for anyone on the boards. About how many pages did your clinical evaluation / clinical trials document come out to be? I'm trying to see if I'm on the right track. Thanks!
For my technical files, the clinical evaluation typically covers a couple of pages. However, part of this is restating the relevant section from the MDD. It will also depend on how many literature references you can find (which I cite – title of paper/book, author, date etc). Be careful on “clinical trials” – totally different beast from “clinical evaluations”.
 
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Roland Cooke

Re: Clinical Evidence and Expert Evaluation

AFAIK there is no requirement for impartiality, just a requirement for competency and completeness.
 
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mathenga

Re: Clinical Evidence and Expert Evaluation

Hi all.

It is my first time posting on the forum. I must also add that this forum is very much informative. I need help with clinical evaluation, just thought of replying to this post as it touches on the subject I am currently bust with at my workplace. I basically work for a company that manufactures class 2b medical device, and we just had a pre audit and the auditor wants to see the clinical evaluation according 2007/42, will it be sufficient to use the clinical data evaluation report of a similar product to prove compliance to Essential requirements annex x. Please advise
 

Marcelo

Inactive Registered Visitor
will it be sufficient to use the clinical data evaluation report of a similar product to prove compliance to Essential requirements annex x.

NO, you have to complete the clinical evaluation of your own device.
 
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