Grouping medical devices as a Single product

A medical device that is sold as a distinct packaged entity and may also be offered in a range of package sizes.

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