The process of CE certification roughly includes the following steps:
Determine product categories and instructions: According to product characteristics, determine EU directives and certification models, such as Medical Device Directive (MDD) or Medical Device Regulation (MDR).
Preparation of technical documents: this is the core of CE certification, and detailed product technical documents need to be prepared, including product description, design principle, manufacturing process, performance evaluation, risk evaluation and other materials.
Selection of certification bodies: select certification bodies recognized by the European Union for product evaluation and audit. As the leading contract R&D outsourcing laboratory in China, Yipin Laboratory has close cooperation with many internationally renowned certification institutions, and can provide customers with efficient and professional certification services.
Product testing and evaluation: Certification bodies will conduct strict testing and evaluation of products to ensure that products meet the requirements of relevant EU standards and directives. Yipin laboratory has advanced testing instruments and equipment, which can meet all kinds of testing and evaluation needs.
Issuing CE certificate: If the product passes the test and evaluation, the certification body will issue CE certificate, which proves that the product can be sold freely in the EU market.
As for the requirements of CE certification, it mainly includes the following aspects:
Declaration of conformity: Manufacturers must declare that their products comply with relevant EU directives and standards.
Technical documents: products must have complete and accurate technical documents for certification bodies to audit.
Marking and labeling: products must be marked and labeled according to EU regulations, including the use of ce mark.
Conformity evaluation: products must pass the conformity evaluation of certification bodies to prove their safety and effectiveness.
With its professional knowledge and rich experience in the field of medical devices, Epintek can provide customers with all-round ce certification services, including the preparation of technical documents, product testing and evaluation, communication and coordination with certification bodies, etc. Our goal is to help customers successfully obtain CE certification, open the door to the European market and realize the international development of products.