Can a literature alone be used for the purpose of Clinical Evaluation of a device?

[SK13485]

Hi,

May I know, if literature alone can be used for the preparing the Clinical Evaluation Report of a Class-IIb device? How stringent are the NB's requirements on the CER's?

I'd appreciate if somebody could clarify me the right guidance documents that can be used for the clinical evaluation SOP for EU, Canada, and the US.

The documents that I have are:


1)IMDRF/GHTF-SG5-N2R8-2007-Clinical Evaluation Final Document
2)Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data
3)MEDDEV 2.7.1/4 (For EU)
4)Guidelines on Clinical Investigation 2.7/4 December 2010

Our products are non-investigational devices. May I know, if there is any Clinical Evaluation guidance document that needs to be followed for US and Canada?

It would be great to hear some of your experiences with the auditors regarding the same. Your response in this regard shall be very helpful. Thank you.

Cheers

SK13485

 

[Marcelo]

Re: Can a literature alone be used for the purpose of Clinical Evaluation of a device

May I know, if literature alone can be used for the preparing the Clinical Evaluation Report of a Class-IIb device? How stringent are the NB's requirements on the CER's?

In principle, if literature data alone is strong enough to support compliance with the related essential requirements, it should be acceptable. However, from experience, it's not easy to find strong literature data for most devices, unless you have had clinical investigations performed.

I'd appreciate if somebody could clarify me the right guidance documents that can be used for the clinical evaluation SOP for EU, Canada, and the US.

The documents that I have are:

1)IMDRF/GHTF-SG5-N2R8-2007-Clinical Evaluation Final Document
2)Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data
3)MEDDEV 2.7.1/4 (For EU)
4)Guidelines on Clinical Investigation 2.7/4 December 2010

For the EU, for the clinical evaluation you need to follow MEDDEV 2.7.1/4. The NB-MED and GHTF document may be used if what they say is not against MEDDEV 2.7.1/4.

Canada does not explicitly requires "clinical evaluation", but there's a guide on using clinical data here: Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)

The US does not required clinical evaluation (in the same sense of the EU) at all. In the case of PMSa, clinical investigations are required. In the case of 510(k), some devices may require clinical data to prove substantial equivalence, but this is on a device-per-device basis.

 

[SK13485]

Re: Can a literature alone be used for the purpose of Clinical Evaluation of a device

Hi Marcelo,

Thank you for the clarification.Very clear to the point. For the CER, we are referring to the literature as there were no clinical investigations performed before. I will focus on the Clinical Evaluation SOP for EU now.

Regarding the PMS, I believe EU, and the US has regulations for manufacturers. Does the PMCF studies as part of PMS and the PSUR's for EU require manufacturers to submit or update clinical evaluation reports? If so, is there a timeline? Thank you.

Cheers
SK13485

 

[FoGia]

Re: Can a literature alone be used for the purpose of Clinical Evaluation of a device

One of the purpose of the clinical evaluation is to establish if there is a need for additionnal clinical trials. I haven't seen an account in the news of a product withdrawn from the market because the clinical evidence couldn't comply anymore with the "updated" requirements on clinical evaluation, but theoretically it is possible. The need for clinical trials stems also from the need to demonstrate new products claims or a change in intended purpose.
You have to regularly assess the need for updating your clinical evaluation depending on the (new) data collected. The European directive provide some guideline for implantables for instance, but it's up to the manufacturer to define the timeline.

 

[SK13485]

Re: Can a literature alone be used for the purpose of Clinical Evaluation of a device

Thank you FoGia for your input. We need to prepare clinical evaluation report for a product which has been in the EU market for some time and we don't have any competitors for this product currently. We also have no adverse events from this product till date.

Based on the resources we currently have, the literature is our only way to go for the preparation of CER. I'm sure, literature data alone would be inadequate as Marcelo explained earlier.

Do you know the expectations of NB for the CER? Should we follow the MEDDEV 2.7.1/4 "Table of contents" exactly as mentioned? How much of the details are they going to look into for a class-IIb device?

Thank you,

SK13485

 

[FoGia]

Re: Can a literature alone be used for the purpose of Clinical Evaluation of a device

You will have a hard time defending your position toward your notified body if you just state that you just didn't have the resources to do more than a literature review. You mention adverse events but claims and benefits are equally relevant regarding the clinical evaluation.

From what I have seen the NB's aren't yet on the same level regarding the clinical assessment of the clinical evaluation, many are still relying on a more 'technical' audit of the clinical evaluation.

You can deviate from the proposed table of content mentioned in the MEDDEV as long as you cover the listed content.

 

[SK13485]

Re: Can a literature alone be used for the purpose of Clinical Evaluation of a device

Thank you FoGia, Yes I believe it is all about the auditing skills and their subject expertise. As I said, We don't have any adverse events reported for that device yet. Our devices are still in use in international markets. We don't have any competitors for that product. There were a few before and they aren't active now. So to talk about the design of the product, it is very old. The references we could find are only based on the literature's published in 1950's and 60s. The investigator who performed the clinical evaluation, couldn't find a lot of data as well. He relied on MEDLINE/Pubmed.

Thanks again !
SK13485