Submitting data from an equivalent device

[Talia]

Hello,
We are developing a Class IIb (MDR) device and plan to submit it to MDR as an equivalent device to another device (MDD certified) that we manufacture.
Our goal is to avoid conducting a new clinical trial by using the data from the equivalent device as a reference in our MDR submission.
Does anyone know if we will be required to submit the study protocol, CRF, database, etc., of the pre-market study conducted for the equivalent device? Will post-market surveillance (PMS) data be sufficient?

Thank you.

 

[Ed Panek]

Our interpretation is in order to use the route of equivalence you must have technical documentation access to the equivalent device. If you have that I would involve your certification body in a back and forth to get the next step(s)

 

[Talia]

Thank you for your response @Ed Panek.

We have the technical file available for the equivalent device. The issue we are being challenged with is the availability of the full study documentation (study protocol, clinical study report, database, etc.).

In your experience, do you think these detailed documents will be required for the review process, or will a study summary/scientific publication be sufficient?

Thanks again.

 

[Ed Panek]

I cannot say with any confidence. Our submission is under MDR Article 120 derogation for the next several years.

 

[Talia]

I cannot say with any confidence. Our submission is under MDR Article 120 derogation for the next several years.

Lucky you Many thanks anyway!

 

[shimonv]

Hi Talia,
I don't think your NB has an interest to challenge / review clinical data of a predicate device.
Your clinical evaluation report should be at a high level with study summary and scientific publication.

-Shimon

 

[Talia]

Hi Talia,
I don't think your NB has an interest to challenge / review clinical data of a predicate device.
Your clinical evaluation report should be at a high level with study summary and scientific publication.

-Shimon

Thanks @shimonv !

 

[Raisin picker]

Let me start from the beginning: Your device is implantable, so falls under Article 61(4), right?
You need to provide all clinical data* available (always, ever, for any device). In my NBs opinion, a publication for a clinical trial is less helpful than the final study report. They will not challenge ethics and the like, but the CIP and CIR (according to EN ISO 14155) should be submitted. And of course all available PMS/PMCF data. And all publications not covering your own study. And a PMCF plan including the PMCF trial plan required by Article 61 (4).
If your device is not implantable, the PMCF trial is not required.

*:from all devices you can claim equivalence for

@Ed Panek and everyone: See MDCG 2023-7 for the requirement of TD access/contract

 

[Talia]

Let me start from the beginning: Your device is implantable, so falls under Article 61(4), right?
You need to provide all clinical data* available (always, ever, for any device). In my NBs opinion, a publication for a clinical trial is less helpful than the final study report. They will not challenge ethics and the like, but the CIP and CIR (according to EN ISO 14155) should be submitted. And of course all available PMS/PMCF data. And all publications not covering your own study. And a PMCF plan including the PMCF trial plan required by Article 61 (4).
If your device is not implantable, the PMCF trial is not required.

*:from all devices you can claim equivalence for

@Ed Panek and everyone: See MDCG 2023-7 for the requirement of TD access/contract

Thanks @Raisin picker ! No, our device is not implementable...We will claim equivalence to one of our devices that is MDD certified, which will be removed from the market once the newer device receives MDR approval. From the discussion, it appears that we will not need to submit the study reports, databases, etc., of the clinical trials conducted for the currently approved device. Instead, we will summarize them in the CER and present a comprehensive PMCF plan for the new device.