Global technical service corporation provides you with the general procedures for obtaining CE certification marks for medical devices:

 

　　Step 1: Analysis devices and their traits to ensure them within the scope of MDD. Definitions of devices give specific regulations about medical devices, some of them such as massagers, masks and so on look like medical device but don’t actually within the scope of MDD.

 

　　Step 2: Recognize all basic requirements of the corresponding product. Every medical instruments must meet the intended use set in Appendix I, so recognizing all the basic requirements applicable to them is the first and most important thing to manufacturers.

 

　　Step 3:Confirm that any relevant European harmonized standards are published by the European Committee for Standardization (CEN) and the European Electrical Technical Committee (CENELEC) in the official journal of the European Union. For certain medical devices, there may be multiple harmonized standards applicable to. Therefore,  it need to be very careful when confirming which harmonized standards apply to a product.
 

　　Step 4: Ensure products meet basic requirements or the needs in harmonized standards and retain documented information as evidence. Manufacturers should be able to present sufficient evidence such as Test Reports issued by Notified Bodies or other Testing organizations to prove their products meet basic requirement.

 

　　Step 5: Product Classification. According to the classification rules of Appendix IX of the Directive, medical devices are divided into 4 categories.．Ie III, IIB & .127; and III, Different types of products, their access to the CE mark (conformity evaluation procedures) are different, Therefore, it is critical for manufacturers to accurately determine the type of their products.

 

　　Step 6: For manufacturers of Class IIa, IIbIII medical devices, there are questions about how to choose the path to the evaluation process when determining the Correspondence Evaluation Procedure. The main difference is the choice of the type test or the way to choose the quality system, each of which has its own characteristics.Manufacturers should choose the most suitable route according to their actual situation.

 

　　Step 7: The main difference is the choice of the type test, or the way to choose the quality system, each of which has its own characteristics. On the list of notified bodies announced in the official journal of the European Union, there are strict regulations on the medical device certifications that can be performed by each notified body and the methods of conformity assessment procedures that can be carried out. Manufacturers must be very cautious when selecting the notified bodies to avoid unnecessary losses.

 

　　Step 8: Drafting a Declaration of Conformity and attaching a CE mark can be said to be an important document. Each device must include a declaration of conformity as described in the appendix to the medical device directive.