EU Medical Device Regulation (MDR) is the new standard for medical technology developers in the EU
As of May 2021, European Union (EU) Medical Device Regulation (MDR) is the new binding legislative act for medical technology developers in the EU. Replacing the previous Medical Device Directive (MDD), EU MDR sets higher standards for safety and performance, provides more transparency and accountability, and aims to strengthen the confidence of patients and healthcare professionals.
Products manufactured by MedTech developers in compliance with EU MDR meet the highest standards and gain access to the EU market. Under EU MDR, MedTech developers must meet stricter requirements and devices more rigorously assessed before they can be approved and marketed in the EU.
MedTech developers are now required to actively monitor the performance of their devices once they go to market and report any adverse events or safety issues, to ensure that any potential risks or defects are identified and addressed promptly for patient safety.
EU MDR also introduces a new classification system to categorize medical devices based on their risk level. This allows for a more targeted and comparative regulatory approach, with higher-risk devices subject to more exacting requirements.
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