What is the EU Medical Device Regulation (MDR)?

The Medical Device Regulation (MDR) was established in 2007 and then revised for the first time in 2017. It is the successor of MDD and applies to manufacturers of medical devices sold or exported into Europe, excluding products used inside the EU but may include those marketed outside it. The MDR defines what exactly needs to be done by medical device manufacturers in order to comply with the regulatory requirements. It includes a few different requirements for medical devices and also requires all products to have CE marking on them.

The MDR applies to any type of medical device, including software that is used by those devices (MDS). Some other types of regulations may only be applicable to specific groups or industries – such as the MDD, which applies to devices used inside the EU.

The MDR is a regulation that manufacturers need to comply with in order to sell their products within Europe safely and without any legal risk. It’s also important for these companies’ compliance officers or managers, who are responsible for making sure everything is done according to this law so that products can be sold in Europe.

Changke Connect has started the MDR registration, hopefully we can get MDR in the first half of 2024.