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Device Grouping & Variants

Overview​

A single device registration application can cover multiple variants, sizes, or configurations of the same device, provided certain conditions are met. Understanding MDA's approach to device grouping can significantly reduce the number of separate registration applications and fees.

When Can Devices Be Grouped?​

MDA permits grouping of multiple devices under a single registration when:

  1. The devices share the same intended purpose
  2. The devices are manufactured by the same manufacturer at the same site (or sites covered by the same QMS)
  3. The devices are of the same generic type (same design principle, same materials, same mode of action)
  4. Differences between variants are limited to:
    • Size (different dimensions of the same design)
    • Configuration (e.g. different handle lengths, different barrel volumes of the same syringe design)
    • Packaging (same device, different packaging quantities)
    • Labelling (different trade names for the same underlying device, same manufacturer)

What Cannot Be Grouped?​

Separate registrations are typically required when:

  • Devices have different intended purposes or clinical indications
  • Devices use different design principles or operating mechanisms
  • Devices are manufactured by different manufacturers or at different sites not covered by the same QMS
  • Devices fall into different device classes
  • Software with materially different functionality (different SaMD versions should be assessed individually)

How to Present Variants in a Registration Dossier​

When grouping variants under a single application:

  1. Device identification table — list all model/catalogue numbers, sizes, and configurations covered
  2. Variant justification — explain how each variant differs from the reference/representative model
  3. Worst-case approach — demonstrate conformity assessment for the "worst case" variant (e.g. largest size, highest energy, most complex configuration)
  4. Risk assessment coverage — confirm the risk assessment covers all variants
  5. Labelling for all variants — include labels for all included models

Representative Device / Worst-Case Selection​

For conformity assessment purposes (testing, clinical evaluation), it is acceptable to test a representative device from the product family rather than every variant, provided:

  • The representative device is justified as the worst case for each applicable test
  • A matrix is provided showing which test data applies to which variant(s)
  • Any variant that is not adequately covered by the representative device data must be separately tested

Adding New Variants After Registration​

If a new variant is added to an already-registered product family:

  • Minor variation — if the new variant is clearly within the scope of the existing registration (e.g. a new size within the already-registered range): submit a minor variation application
  • Major variation or new registration — if the new variant introduces a materially different design element or extends the intended use: may require a major variation or new registration
Plan the Family from the Start

If you have multiple sizes or configurations planned, submit them together in the original registration application. Adding variants later as variations is slower and incurs additional fees. Present the complete product family upfront where possible.