馃殌Clinical Evaluation of Orphan Medical Devices under MDR: 聽A Clear Path Forward
The MDR’s heightened clinical evidence requirements creates challenges for orphan devices. 聽It is especially due to the difficulty of generating pre-market clinical data in small or vulnerable patient populations.聽
馃搫MDCG 2024-10 acknowledges these challenges and highlights that Orphan Medical devices may gain market access with limited pre-market data. This limitation should be balanced by robust non-clinical evidence and an adequate PMCF plan to ensure appropriate collection of post-market clinical data.
馃 聽HaMaDa specializes in overcoming these challenges聽-Contact us to see how HaMaDa can help you navigate these challenges. We will support you in addressing unmet medical needs by developing tailored clinical evaluation strategies, optimizing PMCF plans, and ensuring transparency to meet regulatory expectations.
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