Do you have any further questions? We are happy to assist you via e-mail, phone or let’s have an online-meeting.
The European In Vitro Diagnostics Regulation (IVDR) came into force in May 2017, replacing the previous In Vitro Diagnostics Directive (IVDD) in May 2022 after a five-year transition period. Until May 2027, the specifications will gradually become valid for the individual product risk classes.
Scientific validity means that an analyte is associated with a specific clinical condition or physiological state (IVDR, Article 2 (38)).
Analytical performance refers to the ability to correctly detect or measure a specific analyte (IVDR, Article 2 (40)).
Clinical performance describes the ability to provide results that correlate with a specific clinical condition or physiological or pathological process or state (IVDR, Article 2 (41)).
In order to assess the performance of a device before it is placed on the market, manufacturers must identify all available data on the device, its intended use and safety, and fill in data gaps. Unanswered questions require the performance of appropriate studies (IVDR, Annex XIII, Part A, 1.2).
After market introduction, manufacturers should proactively collect and evaluate performance and scientific data resulting from the use of the device to ensure safety, performance and scientific validity throughout the lifetime of the device and to identify any risks (IVDR, Annex XIII, Part B, 4).
Do you have any further questions? We are happy to assist you via e-mail, phone or let’s have an online-meeting.
The European In Vitro Diagnostics Regulation (IVDR) came into force in May 2017, replacing the previous In Vitro Diagnostics Directive (IVDD) in May 2022 after a five-year transition period. Until May 2027, the specifications will gradually become valid for the individual product risk classes.
Scientific validity means that an analyte is associated with a specific clinical condition or physiological state (IVDR, Article 2 (38)).
Analytical performance refers to the ability to correctly detect or measure a specific analyte (IVDR, Article 2 (40)).
Clinical performance describes the ability to provide results that correlate with a specific clinical condition or physiological or pathological process or state (IVDR, Article 2 (41)).
In order to assess the performance of a device before it is placed on the market, manufacturers must identify all available data on the device, its intended use and safety, and fill in data gaps. Unanswered questions require the performance of appropriate studies (IVDR, Annex XIII, Part A, 1.2).
After market introduction, manufacturers should proactively collect and evaluate performance and scientific data resulting from the use of the device to ensure safety, performance and scientific validity throughout the lifetime of the device and to identify any risks (IVDR, Annex XIII, Part B, 4).
Ask us about
As a renowned regulatory expert and contract research organization (CRO), we provide professional support at every step of the performance evaluation process and also offer a variety of studies that are important for evaluation.
Our study slots
Use our standardized studies and study-slots for rapid-, PCR- and CLIA-test studies to validate your assay: HIV, HBV, HCV, HBsAg, syphilis, SARS-CoV-2, influenza, strap A, RSV, vitamin D, H.pylori and diabetes.
Tailor-made IVD studies
You plan to include specific age groups, sites or disease states? You have specific needs? As one of the very few CROs, we are able to tailor a study to your exact requirements.
What our customers say:
„Thanks to the professional support of IVD TRIALS,
this comparative study was a great success.“ – finddx | Diagnosis for all