Medical Devices CE Certificate – 93/42 / EEC Medical Device Regulation

It is the Medical Devices Ce Certificate regulation, which ensures compliance of medical devices with the conditions within the scope of the regulation, and the devices related to the production, placing on the market and using them in a suitable manner, without posing a threat to the health and safety of people. You cannot market any medical devices that do not have a CE Certificate. A medical device with CE Certificate is deemed to meet all the necessary requirements and is suitable for use by the manufacturer.

Classification by Medical Devices Risk Groups

It falls into a classification according to the risk level of the medical device of the controls and tests to be applied according to the Medical Device Regulations and the controls are applied to high-level risk product groups.

These classes are listed below;

Class I – Low Risk

Class IIa – Medium Risk

Class IIb – Medium Risk

Class III – High Risk

It undergoes some conformity assessment methods / tests for manufacturers to indicate or demonstrate that they meet the basic requirements of medical devices. These methods undergo different processes according to their risk class. Medical products that are tested and evaluated for conformity are given a CE Certificate and CE Mark is attached to the products. All responsibility for placing the CE Mark on the product belongs to the manufacturer. The Ce Label can be attached to the product or its packaging and should be placed visibly.