As summarized in our previous newsletter, CE marking according to the MDR does result in the following changes:

• Use of 3-layered labels (Click here for more information)
• New version of instruction for use
• Changes for 10% PVP in FertiCult^TM Flushing medium:
  1. Stricter endotoxin specification: <0.5 EU/ml
  2. Additional product specification: human sperm survival assay (% motility compared with control after 60 minutes exposure to test medium): ≥80%
• Changes for Spermfreeze^TM/ SpermFreeze^TM SSP:
  1. Intended use does no longer include cryopreservation of testicular and/ or epididymal sperm.
  2. Sperm survival test (SST) is replaced by a human sperm survival assay (HSSA). This means no change in test method, but only a minor difference in calculation of results.
  3. SSP001 is packaged in cardboard box instead of polystyrene box.
• No specific product changes for FertiCult^TM Flushing medium

If additional information is required or additional registration actions in your jurisdiction(s) are required, please send your question to ra@fertipro.com