What is European Union Medical Device Regulation (EU MDR)?

European Union Medical Device Regulation

The European Union Medical Device Regulation (EU MDR) or MDR is a new set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe. Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The EU MDR replaces the EU’s previous Medical Device Directive (MDD) and Active Implantable Medical Devices Directive. Under the new medical device regulation, manufacturers need to provide more in-depth clinical data to demonstrate their safety and performance claims.

What is EUMDR


Why is the EU Medical Device Regulation (MDR) important?

The EU MDR is important because it replaces decades-old legislation with regulations that are more in line with the latest technological advances and medical science and creates a more transparent regulatory framework to improve patient safety. Manufacturers that fail to comply with the MDR could face costly fines, litigation, design changes, product recalls, or lack of access to the EU market.

How do you classify a medical device in Europe?

Medical devices are classified based on the risk that they pose to patient safety along with the following parameters:

  • Duration of use
  • Whether the device is invasive or noninvasive
  • Whether the device is active or not

Devices are classified as either I, IIa, IIb, or III:

  • Class I devices are mostly noninvasive and pose a low risk to patients.
  • Class IIa devices pose a medium risk to patients. They are typically invasive and are installed in the body for less than 30 days.
  • Class IIb devices pose a medium to high risk to patients. They are mostly invasive and may be installed in the body for more than 30 days.
  • Class III devices pose a high risk to patients. They are invasive and are intended to either support human life or prevent impairment of human health.
Who regulates medical devices in European Union?

Medical devices are regulated by national competent authorities within the Member States of the EU. Some medical devices may also be assessed by the European Medicines Agency (EMA) depending on their category.

Source: https://globalregulatorypartners.com

The Essential Guide to EU IVDR Compliance

See if your medical device meets the new European Union (EU) Medical Device Regulation (MDR) requirements and how to stay in compliance in our guide.