Sample of the MEDDEV 2.7.1 rev 4 Clinical Evaluation Report wanted

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Gamula

Involved In Discussions
#2
Dear qc_beginner,

as I know how it feels to wirte a CER without an example I have found 3 links for you:

http://www.parishealthcareweek.com/content/uploads/2017/06/J2_LEGAY_Vincent.pdf

http://www.ctmd2016.com/Sites/328/E... Evaluation and the new MEDDEV 2.7.1rev 4.pdf

These are detailled presentations for you. It helps a lot in trying to find all the data you need and it is good for knowing what to do.

Maybe, you can purchase a good draft under the following link (in German and using bing or google translator you can easily understand it):

Vorlagen fur die klinische Bewertung | Clinical Evaluation Report

Good luck and :cfingers:
 
Last edited:
#5
Dear riri1912 :bigwave: ,

unfortunately the link is invalid and I also cannot find it. :mad:

I have attached two docs - one as a draft, a almost empty draft, and a guideance document. :read:

I hope I could help!

Best
GaMuLa :magic:
Gamula

you LOVELY LOVELY LOVELY person!

this is exceedingly helpful - you're a STAR!!

:)
 

Gamula

Involved In Discussions
#6
:bigwave:

Dear all,

there is a really big matter of concern and I would like to know how do you accomplish the device equivalence in your clinical evaluation report? As you know, "...Manufacturerer must confirm that any difference between the device under evaluation and the designated equivalent device does not affect safety, performance and clinical benefit..." :notme:

If you are not in the good starting position that you can use a device from the same manufacturer welcome on board and share the options you have or choose. The only sucessfull option I was told: By means of a stipulation with another manufacturer it would would be possible. I am thinking of the price you have to pay and the company who would do this. The data needed is very sensitive and it is very unlikely any manufacturer would reveal this kind of data to anyone.

:popcorn: HOW CAN THIS BE SOLVED? :popcorn:


:magic:
 
#7
Hi Gamula

I think that if you are using 'equivalence' then you are already stating that there are other items on the market that are pretty much the same as the one you're working on.
in this day and age, (for the most part at least) I think that a lot of mainstream devices are just re-hashed versions (updated if you will) of existing ones.
if you have something that is novel/new then you likely won't be using 'equivalence' as a tool (at least not in the initial stages).

it can be relatively easy to find information relating to other companies devices through simple searching (at least as a starting block), as many will put information (such as IFU, indications/contraindications and Intended Use on the mountains of paraphernalia that they upload to attract customers). you can then weed out the ones that are too different and only include the ones that are the most similar.
Equivalent devices can be those that are the same in theory, but in practice are for a different purpose (such as a different demographic, or body part); in which case this can actually help you with your justification.

so long as you prove that your device meets the Essential Requirements, then the 'equivalence' path should be relatively straightforward (well...you know what I mean LOL)

you're right, I can't imagine many (if any) manufacturers banding together and saying "yeah - we'll use each other's devices to do equivalence" (although it's a lovely thought! :) )



does this help? or have I got the wrong end of the stick - in which case, apologies and i'll go hide under my desk :) :bonk:
 

Gamula

Involved In Discussions
#8
Hi Kelly,

Indeed, you are right and the option of searching within the world wide web is possible and I think for class 1 devices a way to success. Additionally, I have to smile because this would be so lovely and cute, if manufacturers would stick together. But the reality seems not like :agree: and it seems more harsh.

I try to make an exhaustive comparison of the device under evaluation - our device - and equivalent devices - the plural is intended because I divided the equivalence into three parts: clinical equivalence, technical equivalence, and even biological equivalence. The reason for this is the data you always have about the device and this fragmentation is really helpful. Of course, I have data on my own device for all three fields. There is almost no data available for equivalent devices. I think this is a really funny topic for medical writers / reagulatory affairs manager / and so on....:confused:
 

Krishna Priya T

Starting to get Involved
#9
Hi,

Im a starter in the clinical evaluation report update. Is any filled report available? rather than template. That will be helpful for me to update for my device (class III)
 
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