The European Union Medical Device Regulation (EU MDR) significantly reshaped the landscape for medical device manufacturers, introducing stringent regulatory requirements aimed at enhancing patient safety and device efficacy. Enforced since May 2021, the MDR replaced the older Medical Device Directive (MDD), demanding greater transparency and accountability from manufacturers operating within the EU market.
The final article of the cycle provides clarifications regarding the remaining specific aspects addressed in the document, finalizing the overview of the existing legal framework and highlighting the key points to be taken into consideration by the parties involved.
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
The new article further elaborates on the requirements related to importation of medical devices, and also explains the way adverse events should be handled.
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Medical Devices
