You must do this early in the life of your IVD if you are introducing a new product to the market. One approach to achieve this is to use the appropriate scientific validity information on instruments that measure the same analyte or marker. You may and should, of course, carry out extensive searching of the literature; however, if there is insufficient data, you will have to do out concept, pre-clinical or clinical study proof. Your scientific validity report summarizes all the results, which will be included in your performance assessment report. For further information, see IVDR Annex XIII, Part A.
What is Scientific Validity Report?
Scientific Validity Report are used to evaluate the performance of an IVD device, according to IVD-Regulation 2017/746.
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What is the procedure for producing a scientific Validity Report?
(a) Examine the IVD's stated function and the scientific claims that it makes.
(b) For each of the identified scientific validity claims, a systematic literature search of peer-reviewed literature and additional sources specified above was conducted.
(c) The findings of the literature search are screened, and the literature is evaluated.
(d) The report must be written in a systematic fashion once all relevant material has been obtained.
(e) The report's scientific validity is being compiled.
What are the Most Important Factors to Consider When Developing SVR?
(a)The analytical and clinical performance parts of the Performance Evaluation Report (PER) must be in accord with the scientific validity presented
(b) An IVD's scientific validity is not a one-time operation; it must be confirmed on a regular basis during its existence.
(c) The required literature search must be conducted using pre-defined literature search and selection techniques, which will be recorded in literature selection tables and assembled into a literature search and selection report.
(d) Cycle of revisions with the client to ensure that the scientific validity is properly established.
(e) Scientific validity will assure the benefit-risk ratio's continuous acceptance, as well as the capacity to predict developing dangers based on factual information.
(f) For gathering appropriate information, screening and evaluating data, and compiling an SVR, a mix of scientific, clinical, and regulatory expertise, as well as solid writing abilities, is essential.
What are the many sources of data used to compile SVR?
(a)Data on the scientific validity of devices that measure the same analyte or marker.
(b) Scientific literature (peer-reviewed)
(c) Expert opinions/positions from relevant professional groups that have reached a consensus
(d) Proof-of-concept studies' findings
(e) Clinical performance studies findings
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