Defining the regulatory route for a multi-model diagnostic-device family
A work case on structuring a multi-model IVD family and connecting pathway decisions to the required evidence.
Company and brand names are withheld to protect engagement confidentiality.
Device or product type
An in-vitro diagnostic family sharing a common platform across models with different configurations and accessories.
Challenge
The family scope and pathway-relevant differences were not clearly defined, leaving evidence allocation and preparation ownership unclear.
Basier’s work
Basier structured the product facts, intended purpose, variants, and reference markets, then connected each decision to its source and required information.
Output
A pathway memo, document map, and open-decision register.
What the engagement covered
- Family and variant definition
- Pathway-relevant differences
- Shared and model-specific evidence
What the case shows
Defining device and family scope early reduces contradictions in the dossier and submission plan.
The case does not state an authority decision, review timeline, or registration outcome.