Within the European Economic Area (EEA), the quality of traded goods or products is guaranteed by the CE approval. The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”.
The European Commission provides a classification of the products that require CE approval.
CE approval verifies that the product meets the safety, health and environmental standards according to EU legislation. It is of the utmost importance that medical devices are safe to use and meet the legal requirements that apply when trading within the European Union. The important safety aspects are the risk classification, (clinical) research and the CE mark. Only when the medical device meets the legal requirements, the manufacturer is allowed to put it on the market.
Medical devices are divided into different risk groups. The demands which medical devices have to meet are different for every class. The product has to comply with the relevant regulations prior to being released into the consumer market. The higher the risk for the user of the device and the higher the risk for the patient, the stricter the regulations are.