Can These Models Share One MDMA?

The question can these models share one MDMA is not answered by counting SKUs or comparing names. MDS-G028 provides different routes for a medical-device family, system, procedure pack and IVD grouping. Each route requires evidence in the technical file, labels and catalogues. Commercial similarity does not necessarily create one regulatory unit.

Bundling should produce an application scope that can be defended, not compress a portfolio into one filing at any cost. An overbroad decision may force late separation and file restructuring; an overly conservative decision may duplicate work. The analysis begins with manufacturer identity, intended purpose, class and design, then tests the correct category against product facts.

1 Define the relationship between the products

MDS-G028 defines a single medical device as one that may include different models where they share the basic design, intended use and essential characteristics, and the differences do not affect safety or performance. A family is a group from the same manufacturer with a common intended purpose and class that differs only in features. A system consists of components or parts intended to work together and sold under one name.

These definitions are not interchangeable. Independent models that look alike do not become a system, and components designed to work together should not be forced into a family rationale. Before completing the application, create a portfolio map of every model, accessory, component and kit, whether it is sold separately, and what the label and IFU say about its relationship with other products.

2 Test the medical-device family criteria

The guidance permits a family when the legal manufacturer, intended purpose and risk class are the same, the GMDN code definition is the same if available, and the products share physical design, construction material and manufacturing process. It also sets a maximum of five technical files and fifty items in the application. Those numerical limits do not replace evidence of the qualitative criteria.

To turn this analysis into a product-specific plan, review Medical Device Registration and MDMA Support and the related regulatory insight.

A model difference should not alter safety, performance or the intended purpose. Build a variant matrix covering design, material, software, accessories, sterility, manufacturing method and claims. An additional function, population or performance level needs its own impact analysis even when the company keeps the same family name. The relevant question is what the difference does to intended purpose, class and evidence.

3 Systems and packs are not expanded families

For a medical-device system, the guidance requires the same legal manufacturer, combined use for a common intended purpose, and a technical file that links the components through the label, IFU, brochures, catalogues and clinical evaluation. Only one system is included per application; the highest component class controls where classes differ, with a maximum of five technical files and fifty items including accessories.

A procedure pack may include components from different manufacturers, but the main packs must have one legal manufacturer and share intended purpose, specialty and pack class. The file also needs pack and component documentation, component labels and supply arrangements. The commercial relationship with a component manufacturer is therefore part of submission readiness, not a purchasing detail to resolve later.

4 Bundling decision matrix

5 IVD grouping follows a separate route

Do not automatically apply the non-IVD family logic to IVDs. MDS-G028 requires the same manufacturer name and address, the same risk class, intended purpose and principle of operation, followed by eligibility within the groupings listed in the guidance. The application is also capped at fifty items including accessories.

Before grouping, document the analyte or panel, specimen, clinical purpose, principle of operation, calibrators and controls, and how the result is reported. A difference in these elements can change intended purpose, class or the permitted grouping. The fact that assays run on the same instrument does not establish one application.

6 Connect bundling to commercial execution

MDMA scope needs to remain consistent across labels, IFUs, catalogues, UDI master data and distributor files. If the regulatory file groups models that the catalogue cannot identify precisely, teams may struggle to confirm that an offer, invoice and shipment refer to an authorized item. If products are later separated after pricing and inventory have been built, the launch plan, contracts and demand assumptions may change.

Start with a model-to-evidence table showing each model, reason for inclusion, covering documents, differences, UDI-DI, label and catalogue code. Regulatory, quality and commercial owners should review the same table. This turns MDMA bundling into an operating scope that can be maintained after authorization rather than a filing arrangement inside a portal.

Before approval, challenge three common signals: a partly different claim, an accessory sold independently, or a material or software difference that changes performance. Confirm that each difference is addressed in risk management, verification, clinical evidence and labeling. If those links cannot be shown, build separate grouping and separation scenarios rather than presenting a definitive answer from the item count alone.

Record what bundling does not prove. One application does not make every configuration commercially interchangeable, remove item-level labeling, or eliminate model-specific testing where characteristics differ. Keep enough granularity to investigate each model after market placement and link a complaint or change to the correct identity, evidence and technical documentation.

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