What is the relationship between MDR certification and CE certification?

MDR certification and CE certification are often mentioned in the field of medical devices, and there is a close relationship between them. To help everyone better understand the relationship between these two types of authentication, this article will provide a detailed interpretation of them.

The full name of MDR certification is "Medical Device Regulation", which is a new regulation issued by the European Union in 2017 to replace the original Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). MDR certification aims to strengthen the supervision of medical devices, improve the safety, performance, and quality of products, thereby ensuring the health and safety of patients. This regulation provides detailed regulations on the classification, requirements, clinical evaluation, labeling, and instructions of medical devices, and requires manufacturers to undergo strict evaluation procedures before placing their products on the market.

CE certification refers to a conformity mark that meets the requirements of the European Economic Area (EEA), indicating that the product has passed the EU's safety, health, and environmental requirements and can freely circulate in the EEA market. For medical devices, obtaining CE certification means that the product has met the requirements of MDR regulations and can be sold and used in the European market.

What is the relationship between MDR certification and CE certification? Simply put, MDR certification is a specific manifestation of CE certification. That is to say, if a medical device wants to obtain CE certification, it must meet the requirements of MDR regulations. Specifically, manufacturers need to design, produce, and test products in accordance with MDR regulations, and submit corresponding technical documents and clinical evaluation reports. Only when these requirements are met can CE certification be obtained.

It is worth noting that although MDR certification and CE certification are closely related, they are not the same concept. MDR certification is a specific regulatory requirement, while CE certification is a conformity mark used to demonstrate that a product meets the requirements of the European Union. Furthermore, even if a product obtains CE certification, it does not necessarily mean that it fully complies with all the requirements of MDR. Because MDR certification involves more details and strict requirements, including product classification, labeling, and instructions.

To better understand the relationship between MDR certification and CE certification, we can analyze it from the following aspects:




Target audience: MDR certification is mainly applicable to medical device manufacturers who need to enter the EU market, while CE certification applies to all products that need to be sold in the European market, including medical devices, mechanical equipment, electronic devices, etc.




Certification process: Obtaining MDR certification requires a series of rigorous evaluation procedures, including technical document review, clinical evaluation, etc. Obtaining CE certification requires selecting corresponding conformity assessment procedures based on different product types and risk levels, such as self declaration, third-party certification, etc.




Certification mark: Products that have obtained MDR certification will be marked with the "CE" mark and relevant number on their packaging or instructions to indicate compliance with EU requirements. Products that have obtained CE certification will be marked with the "CE" mark in a prominent position.




Regulatory requirements: Once a product obtains MDR certification and CE certification, manufacturers also need to comply with relevant EU regulations and standards, and undergo regular inspections and supervision by regulatory agencies. If safety hazards or quality issues are found in the product, it may face recalls or other punitive measures.




MDR certification and CE certification are of great significance in the field of medical devices. They not only help improve the safety and quality of products, but also provide a channel for enterprises to enter the European market. However, due to differences in requirements and processes between the two, companies need to carefully understand and follow relevant regulations when applying to ensure a smooth certification process.