Dongguan Xingyuan certification body to provide you with the general procedure for medical devices to obtain CE certification mark:

 

Step 1: Analyze the device and its characteristics to determine whether it is within the scope of the directive. The definition of medical devices is clearly specified in the directive. Some products seem to be medical devices, such as some massagers, masks, etc. Not actually within the scope of the medical Device Directive.

 

The Directive states that any medical device must meet the intended use specified in Appendix I of the Directive, so the first and most important thing for manufacturers to do is to confirm all the basic conditions applicable to their products.

 

Step 3 Confirm that any relevant European harmonised standard is published in the official journal of the European Union by the Committee for European Standards (CEN) and the European Electrical Technical Committee (CENELEC) and that there may be more than one harmonised standard applicable to a particular medical device. So in identifying which harmonized standards apply to it. Great care should therefore be taken in determining which harmonized standards apply to a particular product.

 

Step 4: Ensure that the product meets the basic requirements or the requirements of the harmonized standard and document the evidence. The manufacturer should be able to provide sufficient evidence (e.g. testing by a notified body or other testing body in accordance with harmonized standards, etc.) to demonstrate that the product complies with the basic requirements.

 

Step 5: Product classification According to the classification rules in Appendix IX of the Directive, medical devices are divided into four categories. I. IⅱA, iⅱb &.127; And Class III, different types of products, their way to obtain the CE mark (conformity evaluation procedure) is different, so for manufacturers, how to accurately determine the type of their products, is very critical.

 

For manufacturers of Class Ⅱa and Ⅱb III medical devices, there is a problem of how to choose the path of compliance with the evaluation procedure. The main difference is the way in which type tests are selected, or the way in which quality systems are selected, both of which have their own characteristics. Manufacturers should choose the most suitable way according to their actual situation.

 

For Class Ⅱa, Ⅱb, and III medical devices, as well as Class I medical devices that are sterile or have measurement functions, a notified body should be selected and a compliance evaluation procedure should be conducted. On the list of notified bodies published in the official journal of the European Union, there are strict regulations on the certification of medical devices that each notified body can engage in and the procedures for conformity evaluation that can be carried out, and manufacturers must be very careful when choosing notified bodies to avoid unnecessary losses.

 

Step 8: Draft the Declaration of conformity and attach the CE mark. It can be said that the declaration of conformity is an important document. Each device must include a declaration of conformity as described in the Appendix to the Medical Device Directive.