Market Terminology and Regulatory Meaning
The market often calls a determination that a product is “not regulated as a medical device” a “non-medical certification.” In substance, it is not a general quality certification and not a permanent pass for every product in the same series.
What the Result Depends On
- Intended purpose and target users
- Structure, operating principle and method of use
- Technical parameters, risk controls and verification evidence
- Consistency between the submitted dossier and the marketed product
What Companies Should Maintain
After a determination, companies still need version-consistency control for hardware redesigns, software updates, new accessories, instructions, training and promotion. Any change that may alter purpose or risk characteristics should be reassessed.
This article provides general compliance information and cannot replace a formal assessment of a specific product. Regulations, classification catalogues, guidance, and enforcement practice may change; each project should rely on the rules then in effect, the actual product, and formal documents.