Valued customer
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).
- FertiCultTM Mineral Oil
- FertiCultTM High Viscosity Oil, as mineral oil variant with a significant higher viscosity
As summarized in our 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 FertiCultTM Mineral Oil
- Viscosity specification is broadened to <60cP at 30 °C
If additional information is required or additional registration actions in your jurisdiction(s), please send your question to ra@fertipro.com