Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I am drafting a CER for the conformity assessment of a novel Class IIb medical device and am looking for some advice on how to leverage clinical data that was collected using research prototypes. The data consists of both peer-reviewed publications and unpublished data that was collected a single-center study BEFORE the formation of a company to commercialize the device. The data was collected under GCP at a major academic hospital in the European Economic Area with prior review and ethics approval at the country level. The hospital is an investor in the company and the parties have a data-sharing agreement that contemplates regulatory submissions. The PI for the studies is now an owner/executive in the company.

To what extent can this clinical data be relied on to prove, in part, safety and performance for the new device if the prototype and final product can be adequately compared in bench testing to prove equivalency of measurement results?

Thank you very much!

Original Message:
Sent: 3/12/2021 10:01:00 AM
From: Anonymous Member
Subject: Leveraging Clinical Data From Research Prototypes in CER

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I am drafting a CER for the conformity assessment of a novel Class IIb medical device and am looking for some advice on how to leverage clinical data that was collected using research prototypes. The data consists of both peer-reviewed publications and unpublished data that was collected a single-center study BEFORE the formation of a company to commercialize the device. The data was collected under GCP at a major academic hospital in the European Economic Area with prior review and ethics approval at the country level. The hospital is an investor in the company and the parties have a data-sharing agreement that contemplates regulatory submissions. The PI for the studies is now an owner/executive in the company.

To what extent can this clinical data be relied on to prove, in part, safety and performance for the new device if the prototype and final product can be adequately compared in bench testing to prove equivalency of measurement results?

Thank you very much!

If the clinical data you collected from the prototypes can demonstrate technical, biological, and clinical equivalence to your device, then that would be sufficient and you wouldn't need to do more of conducting a clinical investigation. Be aware, however, it's not always that bench testing is sufficient to cover all 3 equivalence aspects.

------------------------------
Lawrence Maddela
Regulatory Affairs Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 12-Mar-2021 10:01
From: Anonymous Member
Subject: Leveraging Clinical Data From Research Prototypes in CER

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I am drafting a CER for the conformity assessment of a novel Class IIb medical device and am looking for some advice on how to leverage clinical data that was collected using research prototypes. The data consists of both peer-reviewed publications and unpublished data that was collected a single-center study BEFORE the formation of a company to commercialize the device. The data was collected under GCP at a major academic hospital in the European Economic Area with prior review and ethics approval at the country level. The hospital is an investor in the company and the parties have a data-sharing agreement that contemplates regulatory submissions. The PI for the studies is now an owner/executive in the company.

To what extent can this clinical data be relied on to prove, in part, safety and performance for the new device if the prototype and final product can be adequately compared in bench testing to prove equivalency of measurement results?

Thank you very much!

Dear Anonymous,

Based on the information you have provided, you should be able to use the data from the clinical study and peer-reviewed publication data generated with the prototype device as long as a careful, documented, analysis of the differences between the prototype and final device is conducted and justified on the basis that the identified differences would have no effect on the study results if the final device had been used in place of the prototype.

To address this question, you should discuss the modifications and provide a substantive discussion of whether they could affect in any way the conclusions reached about the safety or clinical performance of the final device based on studies with the prototype device.

Bench testing would be an important part of this analysis, but there may need to be additional tests or analyses to those normally associated with this device type to fully justify using the data generated with the prototype to support safety and clinical performance of the final device.

You will also need to appraise the clinical data, preferably taking into consideration points made in MEDDEV 2.7/1 Rev 4, such as methodological quality of the data and other considerations, to determine the degree of support that the clinical data can provide.

------------------------------
Maria E Donawa, M.D.
President, Donawa Lifescience
Rome, Italy
medonawa@donawa.com
+39 06 578 2665
------------------------------

Original Message:
Sent: 12-Mar-2021 10:01
From: Anonymous Member
Subject: Leveraging Clinical Data From Research Prototypes in CER

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I am drafting a CER for the conformity assessment of a novel Class IIb medical device and am looking for some advice on how to leverage clinical data that was collected using research prototypes. The data consists of both peer-reviewed publications and unpublished data that was collected a single-center study BEFORE the formation of a company to commercialize the device. The data was collected under GCP at a major academic hospital in the European Economic Area with prior review and ethics approval at the country level. The hospital is an investor in the company and the parties have a data-sharing agreement that contemplates regulatory submissions. The PI for the studies is now an owner/executive in the company.

To what extent can this clinical data be relied on to prove, in part, safety and performance for the new device if the prototype and final product can be adequately compared in bench testing to prove equivalency of measurement results?

Thank you very much!

I agree with the prior replies.  And fully disclose those financial arrangements in the CER.

In similar scenario, I created a change matrix to demonstrate not just what the changes were between a prototype and final design, but also how similar the two versions of product were. We also made the case for each change, that there was no increase risk or safety issue and no reasonable expectation of affecting performance. You have nothing to lose by pointing to your bench data to support your position. Good luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States
------------------------------

Original Message:
Sent: 12-Mar-2021 10:01
From: Anonymous Member
Subject: Leveraging Clinical Data From Research Prototypes in CER

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

I am drafting a CER for the conformity assessment of a novel Class IIb medical device and am looking for some advice on how to leverage clinical data that was collected using research prototypes. The data consists of both peer-reviewed publications and unpublished data that was collected a single-center study BEFORE the formation of a company to commercialize the device. The data was collected under GCP at a major academic hospital in the European Economic Area with prior review and ethics approval at the country level. The hospital is an investor in the company and the parties have a data-sharing agreement that contemplates regulatory submissions. The PI for the studies is now an owner/executive in the company.

To what extent can this clinical data be relied on to prove, in part, safety and performance for the new device if the prototype and final product can be adequately compared in bench testing to prove equivalency of measurement results?

Thank you very much!