What is the European Medical Device Regulation


In everything in life, there has to be a quality control. As humans we make mistakes and sometimes do things that are not in the best interest of the human population as a whole. Therefore, in everything there has to be someone or an organization enforcing quality control to ensure that no one gets hurt. In the United States, we have the Food and Drug department that ensures no company is coming out with a product that is not helpful and to create some sort of standard and regulation. In Europe, they have the European Medical Device Regulation

What do the do?

Basically, their overall job is to regulate medical devices that come onto the european market. They are the gatekeeper for medical devices. They create and withhold the standards for the medical devices being produced and distributed in Europe. The European Medical Device Regulation board has recently expanded to also include certain drugs and anestechits.

Along with creating the standards for drugs and medical devices they create the regulations for the labels of the drugs and devices so that the person receiving the product or the doctor selling the product can ensure that they are giving the best and most complete information possible. It is only fair that everyone knows what drug or product is going into their body.

They also ensure compliance of hospitals and doctors offices that are creating and testing new medical products that are on the market. Basically, people will do desperate things for money. So part of the European Medical Device Regulation is to ensure that doctors and researchers are not offering large amounts of money for people to do outrageous medical things for the name of research.

Recent New Regulations and Major Changes

Recently, some of the regulations have changed. A few of these changes are: The addition of Unique Device Identification. This will allow devices and there production and to be tracked and ensure that the device is working properly and not causing major problems.

Also, some of the definitions of certain medical devices and medical diagnoses names have changed. This is a minor change but can affect the way that doctors and researchers communicate.

Also, they have raised the bar when it comes to safety and risk and EU MDR compliance. There is a relatively new system that manufactures need to report injuries and deaths due to certain medical devices. All the reporting will need to be done within 30 days of the injury or illness happening.
There is also a new classification of risk with medical devices. The European Medical Device Regulation has strengthened its definition of certain terms pertaining to risk. Therefore, anyone in the medical device industry should check this out because devices and drugs that had been previously considered safe or only slightly risky might be reclassified as more risky.


In the end, there has to be some type of regulatory company to ensure the safety of the human population when it comes to new and existing medical devices and drugs. Therefore, Europe has created the European Medical device Regulation board. Similar to the United States Food and Drug department, this board is the safety gate keeper for the people of Europe to ensure the safety and health of its citizens. Along with this, any person or company coming out with a new medical device or drug should look at their website to find the system and way to be sure to be compliant with the European Medical Device Regulation.