We are very pleased to announce that the following products have been CE marked in conformity with the new European In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746) as class B devices:

• SpermMar Test IgG
• SpermMar Test IgG Positive and Negative Control
• SpermMar Test IgA
• LeucoScreen Plus
• HOS Test
• Fructose Test
• EpiScreen Plus

CE marking of these IVD’s according to the IVDR does result in the following changes:

• • Updated instructions for use:
  • • a graphic overview of the methodology is added to each instructions for use.
    • Symbol glossary is added. New symbols used on the labels are:
      
    • Changes per product:
      

      SpermMar Test IgG (positive and negative control) SpermMar Test IgA	The IFUs of the SpermMar Test IgG and SpermMar Test IgA have been separated Update of the introduction and intended purpose Elaboration of the section on specimen collection and preparation Update of the performance characteristics, addition of repeatability and reproducibility Elaboration of storage and disposal information Elaboration of the section on warnings and precautions Update of the bibliography
      LeucoScreen Plus	Change in lay-out Addition of intended purpose Addition of specimen collection and warnings before use Update of performance characteristics Addition of disposal information Elaboration of the section on precaution
      HOS Test	Addition of general information Update of intended use Addition of test principle Addition of specimen collection and preparation and reagent preparation Update of interpretation section, change in classification of a semen sample Addition of limitations and performance characteristics Update of storage/disposal and warnings and precautions
      Fructose Test	Update of general information and intended use Addition of specimen collection and reagent preparation Method: standard curve and samples should be prepared in duplicate Elaboration on section for interpretation Addition of limitations of the method Update of performance characteristics, storage/disposal and warnings and precautions
      EpiScreen plus	Update of general information and intended use Addition of information on specimen collection Update of the section on calculation and interpretation of the result Update of the performance characteristics Update of storage/disposal and warnings and precautions

• New version of instructions for use: please consult the new instructions on the specific product page on our website: www.fertipro.com.
  • Updated labelling:
    • as the products are now CE-marked as class B devices, the Notified Body was involved in the conformity assessment and this is reflected in the addition of the Notified Body number to the CE symbol on the labels.
    • For SpermMar Test IgG (Positive and Negative Control) and
      SpermMar Test IgA: implementation of 3- layered labels.
• Other product specific changes:
  • SpermMar Test IgG (Positive and Negative Control) and SpermMar Test IgA:
    • New graphic design of boxes for the single and complete kits
  • Fructose Test:
    • The primary packaging of Reagent 1 changed from 1x50ml bottle to 2x25ml bottles.
      The total volume of Reagent 1 has not changed and the bottles are of the same type.
  • LeucoScreen Plus:
    • Bottle of Reagent 3 has changed from a 20ml bottle to a 30ml bottle.
      The volume in the bottle has not changed and the bottles are of the same type.
    • As a result, the size of the box of LeucoScreen Plus has also changed.
  • HOS Test:
    • Sterility will no longer be claimed for the HOS Test, although the manufacturing method will not change. Note that the HOS Test is an IVD and as a consequence not to be used for semen preparation during ART procedures.