Clinical evaluation for legacy device

[itscloud]

Hi everyone,

We manufacture class III invasive & implantable device according to the MDR definition, we have MDD CE certifications and now transitioning to MDR.

The clinical evaluation we submitted to the MDD NB was based on literature review of similar/equivalent device,

Is it possible for us to use the same old approach (use of similar/equivalent device's clinical data) to support conformity with the MDR?

I'm wondering if the old clinical evaluation would still be appropriate for the MDR submission, the content of the old report does not qualified for the definition of "clinical data" anymore and it is meaningless right? For we do not have a contract in place to claim equivalence.

Would this leave us the only option of conducting a clinical investigation?

Any advice is kindly appreciated !~

 

[Raisin picker]

Check Article 61 (4 - 6) carefully to understand in which specific cases the contract is required. For all other cases, Annex XIV (3) tells you that ...

It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.

That access can be through an IFU, publications, own lab tests of the equivalent device, SSCP, ...

Regarding your CER, read Annex XIV carefully, then read MDCG 2020-5, MDCG 2020-6, Annex XIV (again). Then compare with MEDDEV 2.7/1, check against MDCG 2020-6 Appendix I. Read MDR Article 61 (1, 3 and 7). Then start creating a new CEP combining the requirements from MEDDEV 2.7/1 and MDR Annex XIV (1.a).

I'd strongly recommend building the new CER from scratch (of course, reuseing appropriate chunks from the old reports), and not trying to change the old CER.

 

[FoGia]

You can lower the required level of evidence if your device is well-established (Art. 61(6)) or if it is considered standard of care (MDCG 2020-6) but for an implant you'll have to get some clinical data (complaints are not sufficient) and you can't use data from similar devices.

 

[itscloud]

Check Article 61 (4 - 6) carefully to understand in which specific cases the contract is required. For all other cases, Annex XIV (3) tells you that ...

That access can be through an IFU, publications, own lab tests of the equivalent device, SSCP, ...

Regarding your CER, read Annex XIV carefully, then read MDCG 2020-5, MDCG 2020-6, Annex XIV (again). Then compare with MEDDEV 2.7/1, check against MDCG 2020-6 Appendix I. Read MDR Article 61 (1, 3 and 7). Then start creating a new CEP combining the requirements from MEDDEV 2.7/1 and MDR Annex XIV (1.a).

I'd strongly recommend building the new CER from scratch (of course, reuseing appropriate chunks from the old reports), and not trying to change the old CER.

The old CER's content is mainly sourced from similar devices' published literature review, but the MDR state that if we use these "Clinical data" we have to demonstrate equivalence right? That is nearly impossible for us to do

 

[Raisin picker]

If it is impossible for you to show equivalence under MDR, you have been very lucky that your NB accepted similar devices under MDD. There the same rules applied (demonstrate equivalence to be able to use the data), just the demonstration of equivalence needs to be more systematic and reproducible.
You will find IFUs on the webpage (it's basically required now), SSCP at Eudamed (soon ;-), maybe FDA submission data. Buy the device to test in your lab.
And then, since this is common knowledge for 5 years now, you did a lot of PMCF activities to get your own data, so no troubles ;-)

 

[itscloud]

If it is impossible for you to show equivalence under MDR, you have been very lucky that your NB accepted similar devices under MDD. There the same rules applied (demonstrate equivalence to be able to use the data), just the demonstration of equivalence needs to be more systematic and reproducible.
You will find IFUs on the webpage (it's basically required now), SSCP at Eudamed (soon ;-), maybe FDA submission data. Buy the device to test in your lab.
And then, since this is common knowledge for 5 years now, you did a lot of PMCF activities to get your own data, so no troubles ;-)

Thank you for your reply : ) we actually made a equivalence claim in our old MDD CER, by comparison of the intended use, operating principle, model, product structure, and we bought their actual product for performance tests. We had physical copies of their IFU and package labels. Combinded with other similar devices' clinical evidence to support our conformity with MDD.

I'm just wondering if these "clinical data" is still applicable for us, for we do not have a contract in place to demonstrate equivalence under the MDR.

 

[Raisin picker]

Check Article 61 (4 - 6) carefully to understand in which specific cases the contract is required.

To word it differently: You do need that contract when all of the following apply:

• your device is implantable and/or class III (Art. 61 (4))
• your device has not been on the market under MDD (or MDR), with no or only minor modifications (marketed by your company) (Art. 61 (4) and (6.a))
• your device is not in that list: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data (Art. 61 (6.b))

Remember to justify according to Art. 61 (7) and read and understand the MDCG documents I mentioned above.

 

[boncki]

Hello, I would like to ask for your advice
Our company produce a medical device which is substance based. It has been classified as class I under the MDD. Now, according to rule 21 of the MDR, it should be reclassified to IIa. Unfortunately, equivalent device used in clinical evaluation under MDD differs with one ingredient from our device - preservative added because of larger pack, which can be opened multiple times (vs smaller, single use packs of equivalent device). So, we can’t prove biological equivalence any more, because not all ingredients are the same.
Do we have to conduct a full clinical trial?
Or demonstrate, through PMCF activities, that our device (already placed on the market) is safe?
Or just prove, through literature review, that preservative added to our device is well known and safe?
Thank you in advance

 

[Junn1992]

So, we can’t prove biological equivalence any more

Indeed the biol. part would not be valid.

Can you find another equivalent device?

Or demonstrate, through PMCF activities, that our device (already placed on the market) is safe?

Did you conduct a PMCF study previously? PMCF as in a proper clinical trial, and not just post market data

 

[boncki]

Can you find another equivalent device?

There is a device which has identical composition (it is almost 100% equivalent) but we can't find any studies using that device. Ergo we can't base our clinical evaluation on that device.

Did you conduct a PMCF study previously?

We have never conducted clinical trials. We considered our device as standard of care, because the device that we claimed to be equivalent is mentioned in a guidelines (unfortunately its trade name is mentioned too) and it is on the market for almost 20 years without any safety concerns. Also state of the art in this area is not changing.
Maybe in case of such well-established technology and low risk, some kind of survey (questionary) will be enough to prove that the device is safe?