Did you go through a lot of detours when you were not able to find the direction when you applied for the medical device CE certification, and you still did not get it done. This article mainly explains several points that need to be paid attention to for CE certification of medical devices, so that you can avoid detours and quickly apply for CE certification of medical devices.
1.Analyze the characteristics of medical devices
Determine whether it is within the scope of EU MDR, IVDR regulations, or MDD, IVDD directives.
2.Confirm applicable basic requirements
The directive stipulates that any medical device must meet the intended use specified in the relevant directive, so the first and most important thing for manufacturers is to confirm all the basic conditions applicable to their products.
3.Confirm any relevant European harmonized standards
The harmonized standards are standards formulated by the European Commission for Standardization (CEN) and the European Commission for Electrical Technology (CENELEC) and published in the official journal of the European Union. For a certain medical device, there may be multiple harmonized standards applicable to it. It is very careful to confirm which harmonized standards are applicable to a certain product.
4.Product Categories
According to the classification rules of Appendix IX of the directive, medical devices are divided into 4 categories, namely I, IIa, IIb and III. Different types of products have different ways to obtain the CE mark (conformity evaluation procedures). Therefore, for manufacturers, How to accurately determine the type of its product is very critical.
5.Ensure that the product meets the basic requirements or the requirements of the harmonized standards and document the evidence (organization of technical documents).
The manufacturer should be able to provide sufficient evidence (for example, testing conducted by a certification body or other testing agency in accordance with harmonized standards, etc.) to prove that the product meets the basic requirements.
6.For the manufacturers of IIa, IIb and III medical devices, there is a problem of how to choose the conformity assessment procedure.
The main difference is the choice of type test or quality system. Both approaches have their own characteristics. Manufacturers should choose the most suitable approach according to their actual conditions.
7.Choose a certification body
For IIa, IIb and III medical devices, as well as sterile or class I medical devices with measurement functions, a certification body should be selected and a conformity evaluation procedure should be carried out. In the list of certification bodies published in the official journal of the European Union, there are strict regulations on the scope of medical device certification that each certification body can engage in and the conformity evaluation procedures that can be carried out. Manufacturers must be very careful when choosing a certification body , To avoid unnecessary losses.
8.Drafting the declaration of conformity and attaching the "CE" certification mark.
It can be said that the declaration of conformity is the most important document. Each device must include the declaration of conformity described in the appendix of the medical device directive.
9.Correctly choose a medical device CE certification consulting service company.
Some companies blindly seek low prices when handling medical device CE certification consultations, while neglecting high-quality service quality. They leave medical device certification consultations to some inexperienced companies. As a result, not only the service quality decreases, but the service quality is more serious. It is a waste of more manpower and material costs that can not be certified, so choosing a high-quality and high-quality service medical device CE certification consulting service company will save you time and effort, and quickly apply for the medical device CE certification.
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