REGULATORY & QUALITY
The route is part of the product.
Regulation is not a final administrative step. It shapes the claims, testing, manufacturing controls, labelling and commercial route from the beginning.
Current working route
For CleverSkin24, the working regulatory strategy targets the lowest-risk general-device route consistent with the narrow intended purpose. Great Britain, the European Union and the United States are being developed in parallel, but each jurisdiction keeps its own legal and evidence gates.
Great Britain
Working target: Class I, non-sterile, non-measuring, subject to final UK classification, conformity route, registration and all applicable requirements before market placement.
European Union
Working target: MDR Class I under the injured-skin rule for the narrow wound-covering function. Rule 21 and other higher-rule triggers remain evidence-controlled until formally closed.
United States
Working target: Class I general wound-dressing pathway. Product-code and exemption questions for the point-of-use two-component technology remain subject to FDA route closure.
No approval language
CleverSkin24 is not described as “FDA approved”, “MHRA approved” or “EU approved”. Registration, listing, conformity marking and regulatory clearance are different concepts and will only be stated when they are actually achieved and applicable.
Quality system direction
The programme is being built around controlled design, risk, supplier, manufacturing, evidence, labelling and post-market processes. External standards and route-specific requirements will be applied to the released product configuration; draft plans and historical records are not represented as final conformity evidence.