Clarity includes knowing the limits.

INTERNAL TESTING — LEGAL AND REGULATORY REVIEW PENDING. Every result is an educational estimate, not an FDA, MHRA or Notified Body determination, and not regulatory or legal advice. The adapted qualification rules are owner-approved for restricted manual testing. Provisional conclusions are not regulatory expert sign-off. Uncertain, conflicting or unsupported cases remain Borderline. Qualification screening and the separate draft classification follow-up do not establish approval, clearance or conformity assessment. UK screening focuses on Great Britain; Northern Ireland needs separate review. IVD pathways, product-specific exceptions, full EU and UK risk classification and market access require qualified expert assessment.