Clinical Evaluation MDR

[lennsy]

Hello everyone.
I am dealing with the topic of clinical evaluation according to requirements of MDR (and also following guidance of MEDDEV 2.7.1 Rev. 4). I would like to ask you for your help in terms of equivalency demonstration. Since MDR makes this topic more stricter - we need to have access to data which actually let us to demonstrate this equivalency. In the situation when we do not have enough data from other manufacturer which let us to make this process reliable - there is a possibility to miss this point as a part of CER and staying focused on literature route, without any clinical investigation?

 

[Ronen E]

Hello everyone.
I am dealing with the topic of clinical evaluation according to requirements of MDR (and also following guidance of MEDDEV 2.7.1 Rev. 4). I would like to ask you for your help in terms of equivalency demonstration. Since MDR makes this topic more stricter - we need to have access to data which actually let us to demonstrate this equivalency. In the situation when we do not have enough data from other manufacturer which let us to make this process reliable - there is a possibility to miss this point as a part of CER and staying focused on literature route, without any clinical investigation?

Short answer: Yes.

Longer answer: You aren't obliged to address equivalent devices. It's only one route that might be open to you, to reduce the need for prospective clinical investigations. Obviously, if you don't meet the minimum requirements for utilising this route, it becomes N/A and you'll have to make do with what you have. The question whether or not a clinical investigation is / will be required in your specific case is not a simple or easy one. We would have to have access to the totality of relevant information (clinical and non-clinical), and delve into the details and nuances to be able to answer it. In principle, there are cases where a literature review could suffice (though it might be a serious challenge under MDR).

Please feel welcome to PM me if you're interested in a more detailed (and confidential) discussion. I will need more details to help you further and I'm not sure it's a good idea to share them in a public forum.

Cheers,
Ronen

 

[Raisin picker]

Ronen is right, you don't need to use equivalency. You do need, however, clinical data, and according to MDR (Art.2 (48)), that's data from your device or from an equivalent device.
There are some exceptions that might be accepted by the NB, if you provide a valid justification: Article 61(10) and WET as in MDCG 2020-6. Or, compliance to a Common Specification, but there is none around yet (regarding MDR compliance of any device type).

But then, regarding the demonstration of equivalency: as long as you don't fall under article 61(5), and that are rare cases, you need to show where the data from the other device comes from. This would of course be the IFU, there might be publications describing some aspects, and you might be able to get that device analysed in a lab.
And as always, if you fear a clinical investigation coming your way, discuss this early with your NB. Some are very open to general questions, although they will not counsel you.

 

[itscloud]

I'm quite lost on this topic for class III implantable device. Since the equivalency route is nearly impossible to do which requires access to competitor's technical documents and we did not conduct clinical investigation. Would that leave us the only option of obtaining clinical data of our own by conducting clinical investigation?

 

[Ronen E]

I'm quite lost on this topic for class III implantable device. Since the equivalency route is nearly impossible to do which requires access to competitor's technical documents and we did not conduct clinical investigation. Would that leave us the only option of obtaining clinical data of our own by conducting clinical investigation?

Hmmm.... let me see...

Yes, I think I would very much want a class III implantable device to go through an orderly clinical investigation before it's cleared for being implanted in me, especially if its manufacturer (read also: developer) doesn't already have hands-on, field experience with equivalent devices that they make themselves!...

It makes sense to me.

 

[Raisin picker]

But then, regarding the demonstration of equivalency: as long as you don't fall under article 61(5), and that are rare cases, you need to show where the data from the other device comes from. This would of course be the IFU, there might be publications describing some aspects, and you might be able to get that device analysed in a lab.

If you have a completely new class III implantable device, you will do a clinical investigation prior to certification (or have that contract as specified). If you have a legacy device (it is already approved under MDD), you can go the equivalence route (as described in Annex XIV (3)) and you will do PMCF studies later on.
In all cases, you must submit sufficient clinical data (according to MDR article 2 (48)).

Read article 61 (4 - 6) carefully and write it down in a more structured way to make it easier understandable.

So, Ronen, better wait a year or two after MDR certification for the result of the PMCF trial ;-)

 

[Klara]

Hallo,
I have a question on a topic related to equivalence demonstration of legacy device certified under the MDD. The device currently is in conformity assessment process under MDR. The IIb class implantable device belongs among WET (MDCG 2020-6). I think that we have sufficient clinical data from postmarket phase for conformity demonstration with relevant GSPR. But notified body requires equivalence demonstration of the device in question to itself under MDD. I would like to ask you is this requirement justified?

 

[Ronen E]

equivalence demonstration of the device in question to itself

What does that mean?...
What bit of the MDR did the NB quote as grounds for their requirement?
Would you please provide the exact quote of what the NB wrote?

I assume you are aware of the following, from MDCG 2020-6 (emphasis added):

Those devices which are well-established technologies [WET] may be able to confirm conformity with the relevant GSPRs via an evaluation of cumulative evidence from additional sources as listed below. Reliance solely on complaints and vigilance is not sufficient.

 

[Klara]

What does that mean?...
What bit of the MDR did the NB quote as grounds for their requirement?
Would you please provide the exact quote of what the NB wrote?

I assume you are aware of the following, from MDCG 2020-6 (emphasis added):

NB wrote: Although the medical device may be considered as WET and level of clinical evidence may be reduced to level-5 and lower, the level-5 means equivalence demonstration therefore we require that equivalence demonstration to be part the sufficient clinical data of the clinical evaluation of IIb and III class implantable devices.
This equivalence demonstration shall be prepared in accordance chapter 3 MDCG 2020-5. Equivalence of the device in question can be demonstrated to the own medical device accordance with point d) chapter 4 MDCG 2020-5.

But I think that this requirement has not a sense. Equivalence is demonstrated for the purpose to using clinical data of equivalent devices in the CER. If I don't need this data why I should I demonstrate equivalence.

I am aware of the MDCG 2020-6 requirement and I hope that retrospective PMCF from 2011 - to present could be considered as sifficient.

 

[Ronen E]

Thanks @Klara

NB wrote: Although the medical device may be considered as WET and level of clinical evidence may be reduced to level-5 and lower, the level-5 means equivalence demonstration therefore we require that equivalence demonstration to be part the sufficient clinical data of the clinical evaluation of IIb and III class implantable devices.

MDCG 2020-6 explains, with regard to implantable WET devices that "Those devices [WET] may be able to confirm conformity with the relevant GSPRs via an evaluation of cumulative evidence from additional sources as listed below [levels 5 and lower]." It doesn't say that you have to start from the highest level (i.e. level 5). That table (all of it) is provided under a title "Suggested hierarchy of clinical evidence for confirmation of conformity with relevant GSPRs under the MDR". Suggested.
Further, the text right under the title says "A suggested hierarchy of evidence and considerations to apply is provided in the table below, ranked roughly in order from strongest to weakest (some variations may apply dependent on the device, GSPR for which evidence is required, and quality of individual data sources)". Again, "suggested", "ranked roughly" and "some variations may apply dependent on the device". I think your NB is overstepping its boundaries by enforcing this table in such a rigid manner as to demand that you comply with level 5, when you are apparently cooperating in an effective manner at level 6 or lower, and also have clinical data on the subject device (not equivalent ones), from 11 years in the field... Please remember that all MDCG guidance documents are not law and should not be enforced to the letter, as law (or regulation). I would have tried to dispute it, and if necessary appeal it formally (there is an appeal route in the MDR).

This equivalence demonstration shall be prepared in accordance chapter 3 MDCG 2020-5. Equivalence of the device in question can be demonstrated to the own medical device accordance with point d) chapter 4 MDCG 2020-5.

I think that what they refer to here is equivalence to other devices your company makes (in case you are relying on data from such devices). Requiring demonstrating equivalence of a device to itself (or a tight group of devices, e.g. a model family, to itself) makes no sense at all.

Equivalence is demonstrated for the purpose to using clinical data of equivalent devices in the CER. If I don't need this data why I should I demonstrate equivalence.

I agree, you shouldn't.

I hope that retrospective PMCF from 2011 - to present could be considered as sifficient.

Please note that PMCF is at the higher end of PMS. To qualify as "PMCF data" the data would have to be of a clinical nature. Not necessarily a full-on clinical investigation/study, but definitely clinical data from the use of the subject device (not equivalent devices, as you stated above), after it's already been placed on the market under the MDD.