Single grouping requirements
Medical devices that cannot be assigned to a Family, System, IVD Test Kit, IVD Cluster, Group or any other device-specific grouping category must be registered individually.
A Single medical device can be identified by its proprietary or brand name with a specific intended purpose. For example:
- Condoms that are are sold in packages of 3, 12 and 144
- A standalone software program that can be used on different CT scanners produced by other product owners