EU Medical Device Regulation

Medical Device Regulation, also known as MDR, is a regulation used in the EU to oversee the manufacturing and selling of medical devices in the EU. This regulation was put in place on May 26th, 2021 and also took the place of a previous regulation known as the EU Medical Devices Directive. Some of the specific aspects of medical devices that the MDR oversees include inspecting the substances used when creating the medical devices. Certain substances are viewed as harmful and are therefore restricted from being used in the manufacturing of medical devices under EU MDR. There are approximately 2,000 substances on the list of substances that do not meet all the requirements. But, these requirements do not apply to IV medical devices. The Medical Device Regulation also applies to devices that contain liquids, including bodily fluids. If there are dangerous substances present in the medical device, then the information must be given to the users so they have knowledge on the contents in the bag, which is why the MDR requires that it is stated. Additionally, it is the company’s responsibility to check their devices for restricted substances. Overall, the EU Medical Device Regulation is a very crucial regulation followed to ensure the safety of all medical devices and the users of the devices.


EU Medical Device Regulation (MDR) Compliance Solutions | Assent. Accessed 26 Mar. 2024.

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