A performance assessment of in vitro diagnostic medical devices is an assessment or analysis of data to check or determine the scientific validity, the analytical performance and, if applicable, the clinical performance of an in vitro diagnostic medical device.
The performance evaluation is intended to scientifically prove that the intended clinical benefit is achieved and that the in vitro diagnostic medical device is safe.
The performance evaluation report is part of the technical documentation. In the performance evaluation, the data on scientific validity, clinical performance and analytical performance are assessed and the clinical evidence derived from this is documented.
Throughout the entire life cycle of the in vitro diagnostic medical device, the performance evaluation and the associated documents are based on the data from the implementation of the plan for the post-market performance review PMPF) and post-marketing surveillance plan.
The aim of the performance assessment is to demonstrate clinical safety, performance and a positive benefit-risk ratio for the designated and intended use of the in vitro diagnostic medical devices.
Three subject areas determine the content of the performance evaluation (IVDR):
Scientific validity describes the relationship between an analyte and a specific clinical or physiological condition.
Die analytische Leistung eines Produkts beschreibt dessen Fähigkeit, einen bestimmten Analyten korrekt nachzuweisen oder zu messen.
The analytical performance of a product describes its ability to correctly detect or measure a particular analyte.
With the performance assessment, you as the manufacturer use suitable means to demonstrate that the IVD that is placed on the market fulfills the basic safety and performance requirements of the IVDR.
An independent performance evaluation (IVDR) is based on scientifically based clinical data and data from the diagnostic examination. If these are already available to a sufficient extent, the performance can be assessed using literature or database searches (including reference products). However, data from performance tests or performance studies is increasingly being requested.
Various sources and databases are used to determine the data, e.g .:
Of the multitude of regulations, the following are particularly noteworthy:
Further regulations apply to clinical trials - e.g .:
We can draw on the extensive experience of our employees in this area and related areas when it comes to the approval of your medical devices, individual questions about this procedure or services related to it.
In addition to our doctoral team, actively practicing doctors with their specialist knowledge of medicine, medical technology and medical informatics are available exclusively for our clients as consultants.
We are happy to answer your questions about independent performance evaluation.
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Our services / content of your independent performance evaluation:
For your in vitro diagnostic medical device we create an independent performance evaluation according to EU regulation 2017/746 IVDR with the following essential content:
In principle, we can accompany you in all points of the procedure. We would be happy to advise you free of charge and without obligation on a possible service package for your specific product / project.
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