Literature search over how many years?

[Vetty007]

Hello everyone,

we have the situation that there is no proper literature search for MD that are already sold for many years or rather there was only a sporadic literature search (its more a unsystematic collection of suitable literature) carried out, but also with wrong search terms and filters, so that the publications filtered out afterwards are actually hardly relevant and thus are only written somewhere on paper, but don't appear anywhere else. As they are not relevant they are also in no way helpful for the CER.
How could that happen? Quite simply, a non-specialist service provider was commissioned with a literature research - formally a great literature research, in terms of content off topic in several respects. Now a new literature search should be made, but since you can't actually fall back on any data - or just wrong ones - the question is how many years the literature research should be made up for now?!? If a product has been sold for 20 years and thus there normally should be literature data for this time, but they are not (exist), 20 years?!
Of Course the company only wants to do a search for the period up to the last literature search and simply ignorr the previously incorrect search.

I'd love to hear your thoughts or experiences on such a situation -thanks for sharing them in advance

 

[Raisin picker]

I can give you a lawyers answer: It depends.
It depends on the device type, or rather, on the literature you can find. If the device type is still topic of clinical investigations, 5 years might be sufficient. If there was no scientific activity for the last 20 years, do an open search, and work with keyword combinations and filters to reduce the number of hits. With PubMed, you now get a bar graph showing the number of publications vs. time.
And don't forget MDR article 61 (10). You are required to define what data you need. If you have own clinical investigations (e.g. PMCF studies), you can easily argue for a shorter search period. Otherwise ...
And, of course, start with the state of the art. You might find guidelines, textbooks, HTAs that reference the most important publications for the device type.
If the company only does a literature search for 3 years, they might hear from the NB ;-)

 

[Junn1992]

Hmm...if it is for CER you will have to justify the timeframe used. What is the search used for? A good guide :: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), MEDDEV 2.7/1 Revision 4 even though old document, has a good section for literature review under A5.

 

[Raisin picker]

Actually, most parts of the "old" MEDDEV 2.7/1 rev. 4 are explicitely applicable for MDR, see MDCG 2020-6, Appendix I.

 

[katezhang]

it really depends.
for the old product with mature practice, it's better to expend the literature search period and provide your justification. For in most cases, clinical articles will more focus on new tech, new device, new treatments, etc.

 

[Vetty007]

Thank you very much for all the helpfull comments - I am very sorry, that I haven't recognized them earlier.
In this Case there are also no own clinical data (escept laboratory data) and the "Intend Use" is mainly bassed on literature. I just tried to reduce the results of a pubmed research with the help of the bar, going back over a period of time until which there is a obvious fall in the amount of publications. Ending up with approx. 1.500 publications, but as this also accounts for several products its not that much per Product, but of course in general.

Surprisingly the NB said nothing, even if they checked the relevant documents. It was the NB of a PLM client, that mentioned that the Literature search nearly doesn't exist and needs to be done, starting from scratch! But the direct NB of the manufacturer accepted everything - they obviously haven't read the literature search results and/or have no idea about these tasks. But this experience made me think about the financial interesst of NB and that they would loose thes company as client if they check them properly.

 

[vaso B]

Thank you very much for all the helpfull comments - I am very sorry, that I haven't recognized them earlier.
In this Case there are also no own clinical data (escept laboratory data) and the "Intend Use" is mainly bassed on literature. I just tried to reduce the results of a pubmed research with the help of the bar, going back over a period of time until which there is a obvious fall in the amount of publications. Ending up with approx. 1.500 publications, but as this also accounts for several products its not that much per Product, but of course in general.

Surprisingly the NB said nothing, even if they checked the relevant documents. It was the NB of a PLM client, that mentioned that the Literature search nearly doesn't exist and needs to be done, starting from scratch! But the direct NB of the manufacturer accepted everything - they obviously haven't read the literature search results and/or have no idea about these tasks. But this experience made me think about the financial interesst of NB and that they would loose thes company as client if they check them properly.

Interesting perspective! I had similar experiences with NBs and initially I thought "ok, if they accept it, I won't bother". However, it all comes down to the manufacturer's responsibility. It is the manufacturer that should do the procedure correctly even if the NB does not notice it. Beacuse think of that: what if a stricter reviewer comes next year, checks the literature search and finds it insufficient? That could cause a big problem

As for the time frame of the literature search, I would say that you need to include data on YOUR DEVICE (or equivalent) since market launch. However, the SOtA search (search on YOUR DEVICE and SIMILAR/BENCHMARK DEVICES) should be up to date and only recent data must be provided (since last SOtA search). For a CER with annual updates, the SOtA should also be updated annualy, thus the search timeframe will be 1 year since last CER. If the CER does not have a proper SOtA, then I would suggest to perform a search covering 1-2 years, so that it is up to date.

I know that MEDDEV does not separte the 2 searches (clinical literature search and SOtA search), however each has a different scope. Even if you combine them in your protocol you shouldn't look for SOtA data since market launch, but only the latest data.

I hope that helps!

 

[Raisin picker]

... financial interest of NB and that they would loose thes company as client if they check them properly.

Dont think so. Currently, the NB have to hire additional personnell to reject new customers (ok, maybe a bit exaggerated). They have no issues with loosing customers.
I would rather think the NB is so logged with projects that they don't find the time to evaluate everything in detail.

The NBs are regularly audited by their national CA, and by the Commission. If your report is checked, the NB will most likely not have to change your current certificate, but they will look much more closely the next time.

 

[Junn1992]

If the initial review was accepted, then just keep it current for the time being is what I would do