We are very pleased to announce that the following products are CE marked in conformity with the new European Medical Device Regulation (MDR, 2017/745).
- 10% PVP in FertiCultTM Flushing medium
- SpermFreezeTM / SpermFreezeTM SSP
- FertiCultTM Flushing medium
We also received our updated ISO 13485 certificate, which can be downloaded on our website.
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