Can someone share a scrubbed version of Clinical Evaluation Plan (CEP)

[MDRexpert]

Can someone share a scrubbed version of Clinical Evaluation Plan (CEP)

Thanks!

 

[Sullen-gent]

Can try this as an overview

 

[Blacks]

A scrubbed version of the clinical evaluation plan (CEP) according to art. 61 and ANNEX XIV of MDR EU 2017/745 would be even better... can someone help?

 

[Weeder]

I find the requirement for the Clinical Evaluation Plan a little bit confusing. MEDDEV 2.7/1 revision 4 provides detailed guidance on how to put together a Clinical Evaluation and defines the various stages from 0 to 4 with typical contents. If you follow this guidance you will end up with a Clinical Evaluation Report. What then is the purpose of the Clinical Evaluation Plan?

Isn't the plan already contained in the guidance? What else would it include? It is just a redundant activity reiterating what is already in the guidance.

Any thoughts? Am I missing something?

 

[Raisin picker]

I think the problem is that the MEDDEV 2.7/1 rev 4 describes the whole process of performing the clinical evaluation, in (maybe too much) detail.
The MDR (Annex XIV) describes the minimal contents that have to be the results of stage 0 (defining then scope), also in much detail. It also contains the requirement of having a CEP and the new clinical development plan.
So, you have to combine the requirements of both documents, adjusted to your specific device. Since both the guidance and the regulation are rather detailed, it should be no rocket science to create an own template. The hard part, in my opinion, is to define the specific contents required by the MDR.
If you browse the book by Ecker et. al. (ISBN 9783751937665), which I do not recommend specifically, you get a better idea of the minds of some of the persons behind these two documents.

 

[Philip B]

I find the requirement for the Clinical Evaluation Plan a little bit confusing. MEDDEV 2.7/1 revision 4 provides detailed guidance on how to put together a Clinical Evaluation and defines the various stages from 0 to 4 with typical contents. If you follow this guidance you will end up with a Clinical Evaluation Report. What then is the purpose of the Clinical Evaluation Plan?

Isn't the plan already contained in the guidance? What else would it include? It is just a redundant activity reiterating what is already in the guidance.

Any thoughts? Am I missing something?

I agree Weeder, it seems a pointless document. We already have a clinical evaluation procedure and report. However, our NB have just requested our CEP as part of the transition process to the EU MDR therefore I'm going to have to create one.

 

[Known]

Hi, we are working on a new device and are about to start the CE process. I was considering consolidating the CEP and literature search protocol into one document. Is anyone doing the same?

 

[Sullen-gent]

Yes you can one document for the CEP and that could include the literature search plan. Then obviously the search output can go into the report and you need to repeat the lit. search plan in the report as well. To me its more convenient than having a lit. search plan and CEP (which is what we use in our current workplace.

 

[Steve M]

Hi, we are working on a new device and are about to start the CE process. I was considering consolidating the CEP and literature search protocol into one document. Is anyone doing the same?

Hi. We are doing this and I agree with @Sullen-gent , it's defintely more convenient.