Medical device MDR certification is a type of EU CE certification, which originated from the EU's medical device CE certification standard. The MDR certification for medical devices was released in May 2020 as a new mandatory certification to replace the EU Medical Device CE Regulation. 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 of 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 safety of medical devices to ensure the personal safety of users and consumers. Although they share the same goal, the new version of the EU Medical Device MDR certification goes far beyond the old certification, including testing the safety, performance, and conformity evaluation of medical devices.
The newly proposed EU MDR certification for medical devices relied on its comprehensive content and scientific testing methods, which had a significant impact on the medical device industry at that time, making the EU's medical device technology more advanced and products entering the EU market safer and more applicable.
