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 FertiCultTM Flushing medium:
- Stricter endotoxin specification: <0.5 EU/ml
- Additional product specification: human sperm survival assay (% motility compared with control after 60 minutes exposure to test medium): ≥80%
- Changes for SpermfreezeTM/ SpermFreezeTM SSP:
- Intended use does no longer include cryopreservation of testicular and/ or epididymal sperm.
- 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.
- SSP001 is packaged in cardboard box instead of polystyrene box.
- No specific product changes for FertiCultTM Flushing medium
If additional information is required or additional registration actions in your jurisdiction(s) are required, please send your question to firstname.lastname@example.org