First, the collection of certified products related to the European Union technical regulations and the European Union (EN) standards, through digestion, absorption, into the enterprise product standards.
Second, the enterprise in strict accordance with the above product standards to organize production, that is, the requirements of the above technical regulations and EN standards, implemented into the enterprise product design and development and manufacturing of the whole process.
Third, the enterprise must build and maintain the quality system in accordance with the ISO9000+ISO13485 standard, and obtain the ISO9000+ISO13485 certification.
General procedure for obtaining CE marking
Currently, some domestic medical device manufacturers (especially some township enterprises) do not understand the medical device directive and do not know how to apply for CE marking. To this end, we briefly introduce the steps required to obtain the CE marking are as follows:
Step one, analyze the device and its characteristics, to determine whether it is in the scope of the directive medical device definition in the directive has been clearly stipulated, some of the products seem to be a medical device, such as some massagers, masks, etc. In fact, it is not in the scope of the medical device directive. In fact, they are not within the scope of the Medical Device Directive.
Step two, confirm the basic requirements of the applicable directive, the directive provides that any medical device must meet the intended use of the directive specified in Appendix I, so the manufacturer, the first and most important thing to do is to confirm that all the basic conditions applicable to their products.
Step 3: Identify any relevant European Harmonized Standards Harmonized standards are standards developed by the European Committee for Standardization (CEN) and the European Electrotechnical Commission (CENELEC) that are published in the Official Journal of the European Union, and there may be multiple harmonized standards that apply to a particular medical device. Therefore, it is important to check which harmonized standards are applicable to it. Therefore, great care should be taken in identifying which Harmonized Standards apply to a particular product.
Step 4: Ensure that the product meets the Essential Requirements or Harmonized Standards and document the evidence - The manufacturer should be able to provide sufficient evidence (e.g., testing by a Notified Body or other testing agency based on the Harmonized Standard) that the product meets the Essential Requirements.
Step 5: Classification of products According to the classification rules in Appendix IX of the Directive, medical devices are classified into four categories. That is, Ⅰ Ⅱ A, Ⅱ B &.127; and Ⅲ, different types of products, its access to CE marking (conformity assessment program) is different, so for manufacturers, how to accurately determine the type of their products, is very critical.
Step six, to determine the appropriate conformity assessment procedures for the IIa, IIb Class III medical device manufacturers, there is the question of how to choose the path of conformity assessment procedures. The main difference is whether to choose the way of type test or quality system, these two ways have their own characteristics. Manufacturers should choose the most suitable route according to their actual situation.
Step 7: Selection of Notified Body For Class IIa, IIb and III medical devices, and Class I medical devices that are sterile or have measurement functions, a notified body should be selected and the conformity assessment procedure should be carried out. The list of Notified Bodies published in the Official Journal of the European Union (EU) contains strict provisions on the certification of medical devices that each Notified Body can perform and the route of conformity assessment procedures that can be performed. Manufacturers must be very careful when choosing a Notified Body to avoid unnecessary losses.
Step 8: Drafting the Declaration of Conformity and affixing the CE markingIt 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 Devices Directive.