Clinical Evaluation Reports per the new MDD 93/42/EEC amendment

lilybef

Involved In Discussions
#1
As per the new MDD 93/42/EEC amendment, a literature review must be included in the Technical File to augment or substitute for new clinical data. As a manufacturer of a Class I device (which has no clinical data to document), I am trying to find the best way to search published papers for information relating to our device to substitute for clinical data. Has anyone heard if the IVD Directive will follow suit? What kind of search engines have people been using to locate this literature? Any help would be greatly appreciated!:yes:
 
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S

SteveK

#2
Quick answer - try google books. Some limitations e.g. sections not there, but the text books out there are a start. Also adverse incidents - you have to include the bad with the good, try MHRA site in UK and FDA (Maude) in the US. There are other reg. sites as well (TGA - Australia).

Just off home. TTFN

Steve
 

yodon

Staff member
Super Moderator
#3
Timely (for me) issue so I'm glad you brought it up.

What says a literature review *must* be included? I've been reviewing the "Clinical Evaluations: A Guide for Manufacturers and Notified Bodies" and it mentions a literature review as an optional means to provide the required data.

In fact, in section 6.1, Data Generated through Literature Search, the opening statement is "Literature searching can be used to identify published clinical data that is not in the posession of the manufacturer..."

So I'm curious if you're getting different direction or reading something that I'm missing.

As far as where to get literature, SteveK offered good advise. Depending on the device type, maybe there are some trade journals that can be searched?
 

Marcelo

Inactive Registered Visitor
#4
What is required per the new amendment is "clinical evaluation", which can be either:

- a detailed review of the literature to show that the device can be deemed safe and effective (and this can only be done if the device is similar to other devices already in the market)

- clinical investigation or

- both.

Please note that this is required for ALL medical devices.
 
S

SteveK

#5
Yodon is right. There are also various trade (and specific medical based) journals out there on the web, there is also pubmed/medline (http://www.ncbi.nlm.nih.gov/pubmed/) etc. However, if you want the full published article online you have to subscribe – but there can be enough info in the abstract (usually given) for a reference/critic in a ‘clinical evaluation’. Also have a look at competitor literature. Marcelo clearly indicates the ‘must’ aspect of a clinical evaluation that is now required. It is unlikely (except for class III devices) that there is clinical investigations data (for investigation read ‘clinical trials’ i.e. ISO 14155-1) out there, though that will tend to be corporate data. So the literature route will be the only source for class I/II devices for most people – as well as any surveys, questionnaires, studies, customer feedback etc you have generated yourself.:2cents:

Steve
 

lilybef

Involved In Discussions
#7
Thanks all for the input. The info from SteveK about using the adverse event databases as well as our own complaints is great! Does anyone use the embase database? Would it be worth it to spend the mucho $$$ for access? :thanx:
 

bio_subbu

Super Moderator
#8
In addition to my previous post please find below Literature Resources for Clinical Research:

Micromedex® – summaries & detailed monographs for drugs, diseases, alternative medicine, toxicological managements, reproductive risks & emergency care

BIOSIS Previews® – biological, biomedical & life science research - traditional, experimental & interdisciplinary subjects & technical notes/letters - includes Biological.

Web of Science® – includes Science Citation Index® & Social Sciences Citation Index®, multidisciplinary indexes to the journal literature of the sciences & the social sciences – useful for conference coverage.

Scopus® – scientific, technical, medical, and social science literature from 14,000 journals - includes patents & Scirus websearch engine

Cochrane Library – Regularly updated collection of evidence based medicine reviews & effectiveness of health care interventions for practitioners/policy makers

Guidelines.gov - evidence-based guideline clearinghouse

ClinicalTrials.gov - NIH clinical trials list

CenterWatch -Clinical Trials Listing Service™,

TOXNET - cluster of databases covering toxicology, hazardous chemicals, environmental health & related areas – National Library of Medicine (NLM)

NCBI Bookshelf – free online books

PubMed/MEDLINE – can limit to items with links to free full text

PubMed Central (PMC) – free digital archive of biomedical and life sciences journal literature, NIH

BioMed Central – open access publisher

MedlinePlus – consumer health information, NLM

Directory of Open Access Journals – many are full text searchable

Regards
S. Subramaniam
 
Q

Quality Mom

#9
Two Questions:

I have a Class 1 U.S Exempt ; Class IIa EU device. Do we need Clinical Investigations? I mean it is really a requirement for Class IIa?

Also, the client wants to use the first pre-validation units ( manf in production) for clinicals on Humans; before the results of the 60601 testing for safety. Do we allow this?

Thanking you much,:truce:
 
M

markvm68

#10
Does anybody know of any companies who do this kind of thing. I've done two of these searches and I'd rather have the device in question used on me than go through the research again.
 
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