Regulation (EU) 2017/745 includes software in the definition of a medical device when it is intended for specific medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Intended purpose is the key.
Decido is not built to diagnose, treat or replace a health professional. Its editorial perimeter is different: make information about foods, utensils, materials and clothing easier to read while leaving the final choice to the person.
Information is not prescription
A label may list allergens, additives, textile fibres, materials, use instructions or nutrition claims. Translating those elements into plain language is decision support. Telling someone what to do for a clinical condition is a different category.
Uncertainty should be visible
Everyday products often sit in grey areas. An additive can be authorised and still have use limits. A material can be suitable for food contact but not for every temperature. A textile fibre can be comfortable for one person and irritating for another.
The useful work is not turning everything green or red. It is separating data, limits, real use and uncertainty. If information is incomplete, the answer should say so.
- make an ingredient list or textile composition easier to read;
- signal when a substance, material or claim needs context;
- separate hazard, risk, dose, exposure and frequency;
- help compare alternatives without imposing one choice;
- show when a question needs a qualified professional.
What it should not promise
It should not promise absolute safety, diagnosis, prevention or treatment. It should not say that a product is suitable for a specific disease. It should not turn personal preference into a rule for everyone.
Conclusion
Decision support means organising available information, not replacing personal or medical judgement. For Decido the line is simple: scan -> understand -> decide. The final step remains yours.
Fonti citate
- Regolamento (UE) 2017/745 sui dispositivi medici.
- Regolamento (UE) n. 1169/2011 sulle informazioni alimentari ai consumatori.
- Commissione europea, Nutrition and Health Claims, Regolamento (CE) n. 1924/2006.
