Medtech Magazine: MDR Certification Success Hinges on Efficient Processing

A recent article sponsored by RISE MNB details strategies for manufacturers seeking expedited Medical Device Regulation (MDR) certification. While the transition to MDR has resulted in average processing times of 12 to 18 months across Europe, RISE MNB reports successfully achieving certification for some manufacturers in just six to nine months. The article emphasizes that this accelerated timeline is attributable to specific, proactive strategies rather than the simplicity of the medical devices themselves. A key success factor is the integration of regulatory and quality compliance from the initial product development phase, ensuring a strong foundation for subsequent review. Furthermore, the piece highlights the importance of active manufacturer engagement. This includes prioritizing open communication, promptly addressing inquiries, and proactively engaging with the chosen notified body to confirm adequate scope and capacity. Maintaining transparent, solution-oriented dialogue throughout the entire certification process is also crucial.