Group grouping requirements
The Group comprises of:
- A single proprietary Group name.
- Labelled and supplied in a single packaged unit by the product owner.
- A common intended purpose.
The medical devices collected in a Group is a closed list of devices included in a product registration submission. This closed list of medical devices may differ in the number and combination of products, while maintaining the same proprietary Group
name and common intended purpose.
Typically, for a Group, the product owner intends to supply a collection of customised medical devices for a specific medical purpose within a single packed unit, such as a convenience pack or tray, which is under a single name.
The product owner who assembles a Group together is responsible for the Group and its intended purpose.
Medical devices registered within a Group must have a Single medical device registration before being sold separately as individual medical devices for their specific individual intended purpose or as replacements.
Other relevant details required for a Group grouping of medical devices include:
- Sterility.
- Shelf life.
- Evidence on use and compatibility as a group.
- Quality management systems.
- Labelling clearly describing the common intended purpose.
Additional requirements
If the medical device is owned by other product owners, evidence must be submitted to show the safety, quality and efficacy of the device.
If a medical device in a Group is supplied for use in another Group, the medical device must be included in the registration application of that other Group.
The following details must be included in product labels:
- Group name
- Content list of devices within the single packaged unit for supply
- Common intended purpose
Note: Individual medical devices in the Group do not need to be labelled with that Group name.
Examples
What is a Group
- A first aid kit comprising medical devices such as bandages, gauzes, drapes and thermometers, when assembled as one package for a common purpose by a product owner.
- Dressing trays customised with different quantity and type of gauze and sutures which are supplied to different hospitals, while maintaining the same Group name for the trays and the common intended purpose.
- The product label for the trays should bear the content list of devices within the package for supply.
- Some devices in the Group may be individually packaged and labelled, while others are in bulk form and may not be labelled. The product owner shall account for these during the assembling of the Group and ensure compliance to existing regulatory
requirements including traceability of individual devices packaged into the trays and record keeping.
What is not a Group
A promotional pack or convenience pack:
- Without a Group name.
- Without a common intended purpose.
- Consisting of different number of medical devices, for example multi-purpose solution, saline solution and contact lens case.
Individual medical devices shall require registration as Single medical devices.