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What Is CE Authentication, the Process Introduction of Medical Device CE Certification

  Author:MeCan Medical–ultrasound machine manufacturers

CE certification is a very necessary certification in the EU market. Only by passed CE certification can manufacturers sell products in the European Union. Therefore, whether it is the product produced by the EU's internal enterprises or the products produced by other Guo families, if you want to circulate freely in the EU market, you must add the "CE" logo to show Basic requirements. This is a compulsory requirement for EU law to put forward products. Let me introduce the process of CE certification of medical device.

 

 

 

 

Step 1. Determine and analyze export equipment to determine whether it is within the range of the three medical equipment instructions in the European Union.

 

 

Step 2: Confirm the basic requirements for applicable

 

The instructions stipulate that any medical device must meet the expected use specified in the relevant instructions, so for the manufacturer, the first thing to do is to confirm all the basic conditions for its products.

 

 

Step 3: Confirm the relevant European coordination standards

 

 

Coordination standards are the announcement of the announcement of the European Union Magazine by the European Standard Huai Council (CEN) and the European Electrical Technology Commission (Cenelec). For a certain medical device, there may be multiple coordination standards for it. Therefore It is very careful to confirm which coordination standards are suitable for some products.

 

Step 4. 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.

 

 

Step 5: Determine the corresponding compliance evaluation procedure

 

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 type tests, or the method of selecting the quality system. These two ways have their own characteristics. Manufacturers should choose a suitable way according to their actual situation.

 

 

Step 6. 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, testing by certification agencies or other testing agencies based on coordination standards, etc.) to prove the product meets basic requirements. Manufacturers should establish a quality system, conduct product CE trials, and prepare technical documents.

 

Step 7: Select the certification agency for review

 

 

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.

 

 

Step 8, draft a compliance statement and add the "CE" certification logo

 

Each device must include the compliance statement described in the appendix of the medical device instruction.

What Is CE Authentication, the Process Introduction of Medical Device CE Certification 1

 

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