Author：MeCan Medical–ultrasound machine manufacturers
What are the processes of CE certification of medical equipment?
1. Analyze the characteristics of the device to determine whether it is within the scope of the instruction.
2. Determine the classification category of the device.
3. Confirm the application of basic requirements/related coordination standards.
4. Confirm that the device meets the basic requirements/coordination standards and files the evidence (sorting the technical document).
5. Determine the corresponding compliance evaluation procedures.
6. For IIA or higher types of equipment, and category I sterile or measurement equipment, it shall be performed through the announcement agency and a compliance evaluation process.
7. Drafting a compliance statement and paste the CE logo.
What are the precautions during the CE certification process of medical equipment?
1. Product classification. According to the classification rules of the instruction Appendix IX, medical devices are divided into 4 categories, namely I, IIA, IIB, and III. Different types of products have different ways to obtain the CE logo (compliance evaluation procedure). How to accurately determine the type of its product is very critical.
2. Ensure that the product meets the basic requirements or coordinate standards and files the evidence. Manufacturers should be able to put forward sufficient evidence (such as inspection by certification agencies or other testing agencies based on coordination standards, etc.) to prove the product meets the basic requirements.
3. Determine the corresponding compliance evaluation procedures. For manufacturers of IIA, IIB, and III medical devices, there are questions about how to choose a compliance evaluation program pathway. The main difference is the method of selecting the type test, or the method of selecting the quality system. These two ways have their own characteristics. Manufacturers should choose more suitable ways according to their actual situation.
4. Select the certification agency. For IIA, IIB, and III medical devices, as well as II medical devices with sterile or measuring function, a certification agency should be selected and a compliance evaluation procedure should be selected. On the list of certification agencies announced in the EU official magazine, there are strict regulations for the scope of medical device certification and compliance evaluation procedures that each certification agency can engage in. , Avoid unnecessary losses.
5. Drafting a compliance statement and paste the "CE" certification logo. It can be said that the sex declaration is an important document. Each device must include the compliance statement described in the appendix of the medical device instruction.