System grouping requirements
Medical devices under a System have to meet all of the following requirements:
- From the same product owner
- Intended to be used in combination to achieve a common intended purpose
- Compatible when used together as a System
- Sold under a single system name, or the labelling, IFU, brochures or catalogues for each constituent component indicates the constituent components are intended to be used together or for use with the system
The following examples can be grouped as a System:
- A hip replacement system that comprises femoral and acetabular components which are to be used in combination to achieve a common intended purpose. The size of the components may vary.
- An electrosurgical unit and its accessories that comprise of forceps, electrodes, electrode holders, leads, plug adaptor when used together for a common intended purpose.
- A catheter placement set comprising scalpels, syringes, needles, surgical gloves, gauze, drapes and flushing solution that is validated for compatibility and assembled by a single product owner under a single System name for use in combination during
a surgical catheter placement procedure.
How to register products in a System
Devices registered as part of a System shall only be supplied for use with that System.
| Medical devices | Product registration |
|---|
Any device meant for use with multiple Systems | To register together with each of the Systems or to register separately |
Devices meant for use with one or more Systems from different product owners | To register separately |
A product owner may include medical devices or accessories from other product owners as part of their System. These medical devices or accessories should be grouped together as a System.
Information on these devices and accessories, such as authorisation from their product owners for registration with the System, evidence on use and compatibility with the System have to be submitted.
For example, a patient monitoring System from product owner A is to be used specifically with vital signs sensors and probes from product owner B. These accessories can be grouped together with the patient monitoring
System in one application for registration.
A Family of Systems
Multiple Systems may be grouped as a Family of Systems if:
- They are from the same product owner
- They are of the same risk classification
- They have a common intended purpose
- They have a common design and manufacturing process
- Key components have variations that are within the scope of the permissible variants
For example,
automated blood pressure monitors with optional features such as memory storage and print capability for various models.