返回Under the MDR certification for medical devices, it belongs to a type of EU CE certification, which was formerly known as the EU's medical device CE certification standard. The MDR certification for medical devices was released in May 2020, which is a new version and is intended to replace the mandatory certification for EU medical device CE regulations. This regulation has also been approved by all EU member states, which means that products that have obtained MDR certification for medical devices can also enter the EU market for circulation.
Medical device MDR certification mark
It is worth mentioning that the new version of MDR certification for medical devices can be said to be a comprehensive upgrade to the existing testing and certification at that time, with the same goal as the previous CE certification for medical devices, which is to ensure the integrity and harmlessness of medical devices to ensure the personal safety of users and consumers. Although it has the same goals, the new version of the EU Medical Device MDR certification far exceeds the old certification, including testing the safety, performance, and compatibility evaluation of medical devices.
The newly proposed EU medical device MDR certification relied on its comprehensive content and scientific testing methods, which had a great impact on the medical device industry at that time, making the EU's medical device technology more advanced, and making products entering the EU market more safe and applicable.
