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Deciding whether or not pre-market clinical investigation is required for low risk device

DamienL

Involved In Discussions
#1
Hi,
I've a particular scenario that some of you involved in class i or iia might be able to relate to. Our device is a class i device for holding a dressing pad in place - similar to a compression sock. The benefit of our device is that it can be used in place of medical adhesive tape which commonly causes adhesive damage to the skin - so significantly improved benefit/risk ratio over the "predicates" (if I'm allowed use that term). Our device is not in direct contact with the broken skin, it's just holding the dressing in place.

So a pretty straightforward device and before MDR any suggestion of a clinical trial to get this to market would probably have been laughed at. But my interpretation of the MDR is that it doesn't seem to care that our device is low risk Class i, it still wants a clinical evaluation to be based on clinical data (article 61.1) - and that this data has to come from either our own device (via a pre-market clinical investigation) or from an "equivalent" device (article 2.48).

There's lots of clinical data available on the use of medical adhesive tape, so we want to leverage this and avoid a clinical investigation with our own. In terms of equivalence, our device ticks the technical and clinical characteristics boxes in the MDCG guidance 2020-5. But not the biological one - which requires that they be "the same". However, we have plenty of biocompatibility testing done to say our material isn't a concern. The question I have is can we claim equivalence on the basis of MDCG 2020-5 even though our material isn't "the same"? The MDD and Section 3.2 of the guidance seems to suggest we can't, but then 4(a) of the guidance seems to suggest a path: "Consideration must be given to the characteristics mentioned above and a gap analysis should be conducted by the manufacturer to evaluate any clinically significant difference(s)", where the "gap" would be filled in with our biocompatibility testing data.

I imagine this is a common enough scenario, so I'm wondering what people think - can we avoid a pre-market clinical investigation here? If not, then something is seriously wrong with the system.

Thanks,
Damien
 
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dgrainger

Trusted Information Resource
#2
I can't see how your device is technically or clinically equivalent to tape - you seem to be describing a completely different method for keeping the dressing in place and claiming decreased damage to skin.

A CI is the best method of gathering the data to back the claims.
 

DamienL

Involved In Discussions
#3
Thanks for your comments and I completely take your point. However, I'm still very curious as to what leeway can be extracted from the MDR for very simple/low risk devices.

If we just forget about the example I gave as being a bad one, and instead imagine we have any class i or iia device where you've ticked both the technical and clinical characteristics boxes but you use different materials which present no biological risk. In that instance, do you think you could still claim equivalence on the basis of MDCG 2020-5 by filling in the gap with biocompatibility testing? It might be a bit "philosophical" at this stage, but this is one of the simplest device evolutions I can imagine (a stronger/faster material) and I find it hard to understand how the MDR could see value in doing a Clinical Investigation here.

Thanks,
Damien
 

DamienL

Involved In Discussions
#4
Just wondering if anyone can shed some more light on this question for me. Basically looking to find out if the MDR always requires you to do a pre-market clinical investigation if you can't show "equivalence" for a Class i/iia?

The bar for equivalence per Annex XIV(3)/MDCG 2020-5 is so high for a low-risk startup that I'm thinking there must be a way. For instance, if I invented a plaster from a slightly different material than all other plasters, but with enhanced biocompatibility, would I still need to conduct a pre-market clinical evaluation? Article 2.48 seems to say I have to, as I would have no "clinical data" to use in my Clinical evaluation (there would be plenty of data in the literature for similar devices, but nothing for an "equivalent" one). Surely this can't be the case?
 

Philip B

Involved In Discussions
#5
As I understand it you don't need to do a clinical investigation if the clinical safety of your device can be adequately demonstrated via your clinical evaluation (desk based identification, appraisal and analysis of available data) and there are no unacceptable residual risks. We take this approach for our Class I / IIa devices and I don't think this changes greatly under the MDR. The costs of a clinical investigation would blow thousands of low risk manufacturers out of the marketplace, including us. Make sure you have a robust risk file and clinical evaluation (following MEDDEV 2.7/1) and providing you genuinely don't have any unacceptable residual risks then you should be fine. Claim equivalence for those aspects you can, where you can't eg biocompatibility use your own internal data.
 

DamienL

Involved In Discussions
#6
Thanks for the response Philip. What you're saying makes complete sense to me, but I simply don't see the MDR allowing for it. From my reading of Annex XIV part 1.b, the "available data" you talk about for the Clinical Evaluation must be from an "equivalent" device (see article 2.48). There may be plenty of data in the literature for similar devices, but "equivalence" per Annex XIV, part 3 is a different beast. The bar for equivalence is just ridiculously high and seems from MDCG 2020-5 that you can't just "fill in the gaps". So straight away, any start-up is at a dead-end - must do a clinical investigation, even for a class I?

What I'm hoping to get through this thread is for someone to show me that my interepretation above is wrong. If you or anybody else could point to the clauses in the MDR that allow us your commmon sense approach for low risk devices, I would be forever grateful. I do believe it has to be there somewhere, I'm just completely stumped though trying to find it.
 
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