The EU rules and regulations call for medical devices to be labeled with a CE label in order to be marketed in Europe and they must comply with the requirements of the medical device law with regard to safety, performance and lack of adverse health effects. This must be documented in writing as part of the conformity assessment.
Medical devices are distinguished from medical products mainly by their mode of action, in which the intended main effect of the medical device is not achieved by either a pharmacological, an immunological or a metabolic mode of action, but by other means.
In distinguishing products as medical devices from foodstuffs particular attention must be paid to:
- The subjective purpose which the manufacturer assigns to the product
- The objective purpose, which can be derived from the ingredients in their respective concentration, as well as from the established scientific reports on their main mode of action.
- We will assist you in questions of classification as well as in the preparation of the conformity dossiers and the communication with the notified bodies. Call us or write to us.