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.
Medical devices are classified based on the risk that they pose to patient safety along with the following parameters:
Devices are classified as either I, IIa, IIb, or III:
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.
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.