Clinical Development Plan - Advice Requested

[MakingADifference]

Morning all.

How is everyone doing in this crazy world that we live in. I say crazy but maybe 'crazier' is more fitting!

In reference to Annex XIV, section 1a - Has anyone written a Clinical Development Plan? When first-in-man studies and the like have not been performed, what should the plan contain? I am unsure if we are unusual in any way but our product did not stem from exploratory investigations. We have produced a Clinical Evaluation Plan and Report.

Thanks in advance.

 

[shimonv]

Crazy indeed..
Annex XIV is about clinical evaluation; not investigation (Annex XV).
Clinical evaluation is mostly about litrature and database search.
You have to do it, and that circles back to crazy world.

Shimon

 

[MakingADifference]

Hi Shim.

Part of Annex XIV requires a clinical development plan. We have performed our CEP and CER but a request from the NB is to see our clinical development plan.

Annex XIV, Part 1(a) "a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria;"

 

[shimonv]

okay, I didn't notice the section you were refereeing to. What I think you should do is include a rationale in the CEP why PMCF is not warranted.

 

[MakingADifference]

I have no problem with performing PMCF and we have a plan for that already, haha.

I guess I am trying to figure out what this development plan should entail! I feel this is more tailored to 'drug development' as an example. The MDR is still new and not many people have been through it, well people that I know that is! I am hoping someone has been through this and would have an example that they could show. I could then see how applicable it is or where I may need to update our CEP for example.

 

[yodon]

The CEP structure is pretty well described in Annex XIV, Part 1(a). The citation you mention above is just the last bullet point in the list. My take on that point (haven't been through it so take with a grain of salt) is that it's just wanting to know the evolution of how you collect relevant clinical data - starting with your premarket activities. You did something pre-market to give you confidence of safety and efficacy.

 

[PVC Barbie]

I work for a device manufacturer in a similar situation where CDP, as defined in the MDR, was not really appropriate in the sense it would be for some devices (ours is well established technology, low risk and long history on the market). We have a CDP section in our CEP rather than a separate document. With that being said, it hasn't been through MDR audit yet so...fingers crossed it will pass the test!

 

[liz5572]

Same. I work for a medical device mfg with class I-III devices. Agreed that this doesn't have to be a separate document. In the CEP, it can be as simple as a section titled "Clinical Development Plan" with a table with the name of the study (past and future/planned), purpose and status. It gives the reader a feel for what efforts have been taken, and what will be taken - and should align with the data presented in the CER and PMCF plan. Good luck.

 

[Liefie40]

We had literally the exact same thing. We have a legacy product and when I say legacy I mean literally been used in millions since 1958. we have a PMCF, CEP, CER all the works just lacking the Clinical Development Plan and not sure at all how to present it

 

[Marc Benet Pozo]

I am working for a Manufacturer of Class IIa medical devices, and we are currently updating Clinical Evaluation process to the new MDR. So, Could you please share you CEP? we already have well established the procedure and the CER, but don't know what the CEP should look like.