Analytical Performance Services
Have you heard? Since May 2017, the In-Vitro Diagnostic Directive (IVDD) is replaced by the new In-Vitro Diagnostic Regulation (IVDR). IVD device manufacturers have a five-year transition period to be fully compliant with all changes as set forth within this new regulation. A significant number of definitions will change, which may result in products currently not classified as an IVD device or accessory under the IVDD being included in the scope of the IVDR.
Your technical documentation needs to contain the results and critical analyses of all design verifications and design validation tests studies undertaken to demonstrate conformity of the device with the general safety and performance requirements of the IVDR.
Since the results will be used in regulatory submissions, it is essential that all data are obtained in line with the harmonized standards and applicable CS (Common Specifications) when available. We always use the most recent versions of the CLSI guidelines. In the new IVDR, typical analytical performance studies to be performed, according to harmonized standards, are:
Validation steps including CLSI guidelines
|Description||Involved CLSI guideline|
- Reportable range
- Measuring range
- Assay reportable range
- detection limit
- limit of detection
- analytical sensitivity
- cross contamination
- matrix effect
- method comparison
- diagnostic accuracy
- specimen type
- matrix comparison
- expected values
- shelf-life stability
- in-use stability
- stress testing (shipment)
What we can do for you
Future Diagnostics offers analytical performance services to IVD (immuno) assay manufacturers for a seamless transition to the new IVD Regulation. Before starting the actual studies, it is important to assess the status of the current technical documentation. We give our customers customized advise by performing an assessment on the current technical documentation before starting with the analytical performance studies. Goal of this assessment is to determine which studies are already reported in the past and to determine whether and which additional studies need to be performed to assure compliance of the technical documentation to the new IVDR. It is possible that some of the required studies are already done before. If so, these studies don't need to be repeated. Together with the customer we decide which additional studies are needed. You don't want to do too much, nor too little to have the necessary technical documentation for your assay compliant to the IVDR.
Why outsource the analytical performance studies to Future Diagnostics?
- Future Diagnostics is EN-ISO 13485 certified
- The studies are designed to be compliant with the needed harmonized standards, such as EN 13612:2002, EN 23640:2015 and applicable CLSI guidelines
- We advise you beforehand what needs to be done
- You know that your products are compliant to the new IVDR on time
- Your team stays focused on their regular activities
- We give you peace of mind