A Semantic-Loss Framework for Global Medical Device Classification Interoperability: The G-MDRG Risk-Control Grammar

This v4.2 deposit is a manuscript-only preprint version of a pre-normative regulatory-science methods paper proposing the Global Medical Device Risk Grammar (G-MDRG), a non-binding semantic-risk representation framework for medical-device classification interoperability. This version strengthens regulatory-source grounding, clarifies that proxy and dry-run agreement values are internal computational rule-consistency measures rather than human inter-rater reliability, adds an explicit IVD/IVDR scope boundary, distinguishes legal requirements from guidance, standards, nomenclature, and methodological sources, and frames FDA class-derived comparator analyses as illustrative feasibility stress tests rather than criterion validation. Supplementary codebook, expert-validation protocol, and feasibility evidence files have been prepared for journal peer review and may be released as a later Zenodo version after peer-review processing, acceptance, or further public-record preparation. The work does not provide legal classification, regulatory approval, conformity-assessment evidence, notified-body acceptance, FDA/EU MDR/IVDR conformity determination, clinical validation, certification evidence, or a validated software tool. It is intended only as a research framework and pre-validation methods manuscript.