Grouping of medical devices

Grouping medical devices as a 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.

Grouping medical devices as a Group

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

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.

Grouping medical devices as a 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.

Grouping medical devices as an 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.

Grouping medical devices as an 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.

Grouping medical devices as 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.

Grouping medical devices as Fluorescence In Situ Hybridization (FISH) Probes IVDs

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.

Grouping medical devices as 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.

Grouping medical devices as Immunohistochemistry (IHC) IVDs

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.

Grouping medical devices as IVD analysers

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

Grouping medical devices as 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.