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Grouping of medical devices

Grouping of multiple medical devices for product registration can help save on fees and processing time. Learn about each criteria to help you decide on a possible option for your devices.

Grouping Key criteria
Dental Grouping Terms (DGT)

Dental devices with the same product owner that fall under risk classification Class B, with intended purposes that fall within the descriptor of one Dental Grouping Term.

Hearing aids

Hearing aids with the same product owner that are of risk classification Class B with the same design, sound amplification and communication technologies.

Immunohistochemistry (IHC) IVD reagents

IVD reagents and accessories with the same product owner that fall under the same risk classification B or C, based on IHC methodology and within same IHC Grouping Category

Fluorescence in situ hybridisation (FISH) probes IVD

Reagents and accessories with the same product owner that fall under the same risk classification B or C, based on FISH methodology and within same FISH probes IVD Grouping Category

IVD analysers

IVD analysers with the same product owner, proprietary name, risk classification and methodology, with permissible variants.

In vitro fertilisation (IVF) media

IVF media medical devices with the same product owner that are compatible when used together, and are intended to be used for an IVF procedure and falls within the same IVF Grouping Category

Family

Medical devices with the same product owner and common intended purpose, and design and manufacturing processes. Variations need to be within the scope of permissible variants.

System

Medical devices with the same product owner that are meant to be used in combination with a common purpose, and are sold under a single system name or label or labelled for use together with the system.

Group

A collection of two or more medical devices that is labelled and supplied in a single packaged unit for a common intended purpose.

Single

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

IVD Test Kit

Reagents or articles with the same product owner that are meant to be used in combination for specific intended purpose. They are sold under a single test kit name or labelled for use with the IVD test kit.

IVD cluster

IVD reagents or articles with the same product owner that only fall under risk class B. They are of a common test methodology and fall under the same IVD cluster category.

If you are unsure whether your medical devices can be grouped together in a product registration application, please complete the Grouping Enquiry Form and List of Configurations of Medical Devices and submit it to us for advice.

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