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).
- VitriFreeze™ / VitriThaw™
- VitriFreeze ES™ / VitriThaw ES™
- FertiVit™ Cooling / FertiVit™ Warming
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
- Change of color of the caps: all cooling/freezing media will have blue caps.
All warming/thawing media will have green caps
- Specific changes for FertiVit™:
- Volume of FertiVit™ Cooling 5 was increased from 1 ml » 1.5 ml
- Volume of FertiVit™ Warming 1 was increased from 5 ml » 7.5 ml
If additional information is required or additional registration actions in your jurisdiction(s), please send your question to email@example.com