Sample of the MEDDEV 2.7.1 rev 4 Clinical Evaluation Report wanted

T

TechnicalGuy

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:


It would be great if there was a database we could upload all the confidential information to which only NBs or Health Authorities could access. I.e. we say my device is equivalent to this device.... then they go off and judge for themselves! Would make the process so much easier. Only problem is....hackers!
 
Q

qc_beginner

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:

Dear GaMuLa,

Thank you.

I saw your writing late.

It is a great help to me.

It is becoming increasingly difficult to create clinical evaluation reports.

I am now going to insert content related to 'state of the art' in my report.

This is also difficult.
 
S

Sudhakar Bangera

Anyone who could help on CER for Scalp Vein, tube (NG, Peritoneal dialysis, hemodialysis, endotracheal), nebuliser, oxygen mask, suction catheter. Trying to start writing for the above products. So need guidance and templates. Help appreciated.
 

Gamula

Involved In Discussions
Anyone who could help on CER for Scalp Vein, tube (NG, Peritoneal dialysis, hemodialysis, endotracheal), nebuliser, oxygen mask, suction catheter. Trying to start writing for the above products. So need guidance and templates. Help appreciated.

Dear Sudhakar,

it seems that you have a big variety of devices, thus, CERs for every indication (try to sum up as many devices as you can) because CER is just a cofirmation of the indication. Furthermore, try to obtain the equivalent devices (in my eyes this is the toughest part beause you need reliable available data, which almost no other company will provide you). Than, divide the biological, the technical and chemical properties and start the literature search. Afterwards, you can start writing. BUT, I always recommend a team because you need knowledge, deep knowledge from different fields.

OR

Buy one from an service provider first, I mean let them write one with your data, learn how to do it, start your own.

OR

Do multifarious tests and make linkings from the CER to your technical documentation (still needing equivalence!)

I hope it helps you in the CER jungle.

:magic:
 

Gamula

Involved In Discussions
Dear GaMuLa,

Thank you.

I saw your writing late.

It is a great help to me.

It is becoming increasingly difficult to create clinical evaluation reports.

I am now going to insert content related to 'state of the art' in my report.

This is also difficult.

Hi, no problem! Regarding state of the art, it is not so hard, just finding and reading a lot of papers, if you are not having a completly new innovative device. Good luck!
 
S

Sudhakar Bangera

Dear Sudhakar,

it seems that you have a big variety of devices, thus, CERs for every indication (try to sum up as many devices as you can) because CER is just a cofirmation of the indication. Furthermore, try to obtain the equivalent devices (in my eyes this is the toughest part beause you need reliable available data, which almost no other company will provide you). Than, divide the biological, the technical and chemical properties and start the literature search. Afterwards, you can start writing. BUT, I always recommend a team because you need knowledge, deep knowledge from different fields.

OR

Buy one from an service provider first, I mean let them write one with your data, learn how to do it, start your own.

OR

Do multifarious tests and make linkings from the CER to your technical documentation (still needing equivalence!)

I hope it helps you in the CER jungle.

:magic:

Thanks. Let me try getting my hands dirty by doing it myself. If I had a rough template, at least I would know where to start from. I do Clinical Study Report for Pharmaceuticals based on ICH E3. Was wondering if there was something like E3.
 

theresareeb

Registered
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:
Hi Gamula,

Even though you posted the issue a while ago, I was wondering whether you are willing to share how you solved it / if you were able to solve it? In my opinion, especially for MDR conformity, in such cases as yours you would have to do comparative investigational studies with the devices.
I'd love to hear your experience on that.

Any other opinions are highly appreciated!
 

Gamula

Involved In Discussions
To be honest, collect data like papers and so on, reference on as much papers and existing data as possible and find many reference devices.....500 pages for 2 CERs for submission was successful. Thus, we could avoid comparative investigational studies. only some tests reports needed to be updated and expanded. But, this was only possible with an external consultant to be in MDR line completely.
 

theresareeb

Registered
To be honest, collect data like papers and so on, reference on as much papers and existing data as possible and find many reference devices.....500 pages for 2 CERs for submission was successful. Thus, we could avoid comparative investigational studies. only some tests reports needed to be updated and expanded. But, this was only possible with an external consultant to be in MDR line completely.

Congrats! How did you manage to prove the equivalence in all aspects, without data access?
When you say you found many reference devices, I assume you did not claim equivalence to them to avoid that prove?

I guess without sb having practical experience in the topic, it's a rough project!
 
Top Bottom