Regulatroy Consultant

CE Marking on labels and packing of medical devices proves that medical devices meet the current EU medical device regulation or medical device manufacturer’s claim that a product meets the General Safety requirements of all relevant European Medical Device Regulation. The Regulation outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark for medical devices is a legal requirement to place a device on the market in the European Union Countries. Before placing a CE marking on a medical device, the device must follow the definition of medical devices and be classified correctly in accordance with the classification rules laid down in annexe VIII of the EU MDR 2017/745. Medical devices are divided into four risk classes: I (Im, Is), IIa, IIb and III. Class, I medical devices are lower risk devices, while class III medical devise are the highest risk devices. The manufacturer of a class I device is responsible for the self-declaration of the CE marking process. A notified body must be involved in the certification of medical devices belonging to higher risk classes. To know more visit https://bit.ly/3kKvolz