Everything you need to know about the European MDR

The medical device landscape in Europe has undergone significant changes with the introduction of the Medical Device Regulation (MDR), which came into full effect on May 26, 2021. Focus is given to set a higher standard for the safety, performance, and quality of medical devices across the European Union (EU). For manufacturers, healthcare providers, and patients alike, understanding the implications of MDR is key to navigating this evolving landscape.

One of the most notable changes introduced by the MDR is the requirement for more robust clinical evidence, particularly for high-risk devices. Under the new regulation, manufacturers must provide extensive clinical data that demonstrates the safety and efficacy of their products, including data from clinical trials and long-term studies. This ensures that the devices reaching the market have been thoroughly vetted, providing greater assurance to patients and healthcare providers. For manufacturers, this shift means a significant investment in research, clinical evaluations, and comprehensive documentation.

Another critical aspect of the MDR is the emphasis on traceability. To improve the tracking of medical devices throughout their lifecycle, the MDR introduces a Unique Device Identification (UDI) system. This system allows each device to be identified through a unique code, making it easier to trace devices through the supply chain and enabling faster action in case of recalls or safety notices. 

Post-market surveillance has also been significantly strengthened under the MDR. Manufacturers are now required to implement more comprehensive systems for monitoring the safety and performance of their devices after they have been placed on the market. This includes actively gathering data on device performance and promptly reporting any incidents or adverse events to the relevant authorities. 

In addition to new surveillance and traceability requirements, the role of notified bodies - the organizations responsible for certifying that devices meet regulatory standards - has become more stringent under the MDR. While the number of notified bodies authorized to carry out certifications has decreased, their responsibilities have grown. They must conduct thorough assessments of high-risk devices and ensure that manufacturers meet all regulatory criteria, this has led to a more rigorous certification process.

A central feature of the MDR is the European Database on Medical Devices (EUDAMED), which aims to improve transparency and accessibility of information. EUDAMED serves as a central repository for data on medical devices, including details on manufacturers, notified bodies, and post-market surveillance activities. By making this information more accessible, the database helps ensure that all stakeholders, from patients to healthcare professionals, have a better understanding of the devices being used. At the moment, only a few modules within EUDAMED are active, it is expected to be fully rolled out during 2026.