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

• Use of 3-layered labels (For more information: see previous newsletter)
• New version of instruction for use
• Specific changes for Sil-Select Stock^TM and Sil-Select Plus^TM:
  • 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
  • Viscosity is omitted as specification
• Specific changes for GAIN^TM medium
  • Additional product specification: human sperm survival assay(HSSA) (% motility compared with control after 24 hours exposure to test medium): ≥80%
  • Intended use does no longer include swim-up or density gradient preparation

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