Published Paper Details:

Medical devices are integral to healthcare systems, providing essential diagnostic, therapeutic, and preventive support. The European Union's transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) introduces stricter requirements for safety, performance, and clinical evidence. This manuscript examines the compliance pathway for the EUMDR and its implications for global manufacturers, particularly in maintaining the accessibility of medical devices. Key focus areas include safety and performance requirements, quality management systems, postmarket surveillance, postmarket clinical follow-up, and gap analysis. Strategies for manufacturers to preserve accessibility are discussed, emphasizing the importance of regulatory compliance as a continuous process. These findings highlight that timely adaptation to the EUMDR is crucial for safeguarding patient access to critical medical technologies.