CER - Considering similar device/other medical devices for as relevant literature

[Harini17]

Dear Experts,

It would be great if you could help me to find the justification to the following:

1. Can we consider other devices performing same function in the literature review section as relevant literature and appraising the same. Is that ok to consider? In what way it affects (+/-) the Clinical evidence? In what all situations can we consider? Is there a evidences for consideration from the Regulatory standpoint?

2. Appraisal plan: the table that we are going to consider with certain suitability and data contribution criteria, on what basis are we going to build it, do we have any regulations mentioning that (table)? I didn't find in MDR 2017 o MEDDEV rev 4

3. For state of art section: do we need to perform separate literature search for this section?

If you could answer these questions from the Regulatory and Scientific standpoint, it would be more helpful.

Looking forward to hearing from you soon.

Thank you

 

[bio_subbu]

Hi Harini

My comments are interleaved

Dear Experts,

It would be great if you could help me to find the justification to the following:

1. Can we consider other devices performing same function in the literature review section as relevant literature and appraising the same. Is that ok to consider? In what way it affects (+/-) the Clinical evidence? In what all situations can we consider? Is there a evidences for consideration from the Regulatory standpoint? - Yes, you can obtain data that relate to benchmark devices.

2. Appraisal plan: the table that we are going to consider with certain suitability and data contribution criteria, on what basis are we going to build it, do we have any regulations mentioning that (table)? I didn't find in MDR 2017 o MEDDEV rev 4 - use criteria listed in tables D1 and D2 from Rev 3 or refer Appendix D: A Possible Method of Appraisal of GHTF guidance document on Clinical Evaluation SG5/N2R8:2007.

3. For state of art section: do we need to perform separate literature search for this section?

If you could answer these questions from the Regulatory and Scientific standpoint, it would be more helpful.

Looking forward to hearing from you soon.

Thank you

 

[Harini17]

Thank you so much for your help. Actually we had a debate here that different devices performing same function must be omitted and shouldn't be considered as relevant literature. Most of them came up with different answers and none were convincing from the Regulatory standpoint.

It would be great if you could answer my third question.

Thanks for your time and help.

 

[FoGia]

How I deal with that situation is that I put data on the benchmark device in the state of the art section.
And yes I have already performed systematic literature reviews to support the state of the art section but it usually is to support a specific concept which isn't debated in the literature.

 

[BhupinderSinghPawa]

The Literature Review should provide you with the pertinent articles that would encompass Clinical Background, Current Knowledge, State of Art, Equivalent Device and Clinical Studies with respect to ER's for Safety, Performance, Side Effects and Risk-Benefit Profiles.

In terms of CER documentation, the Literature Review can be in a single chapter, with the relevant articles characterized by their relevance (points above) to Clinical Evaluation or appropriately referenced in other chapters.