Securing Corporate Buy-In & Deploying the Regulatory Transition Plan as a Business Project In-depth Analysis of the NB Redesignation Process & the Impact on Recertification Timelines Practical Approach to Implementing New EU Clinical & Post-Market Requirements
With the release of the European Medical Device Regulation in May of 2017, the three-year transition countdown to articulate updated regulatory strategies began for device manufacturing corporations, notified bodies and EU regulators alike. As the EU MDR will supersede the current directives, and introduces many new requirements, it is pivotal for the industry to secure a strong understanding of mandates, as well as a full perspective of the impact on all operations, starting with re-certification of legacy products, to set acomprehensive and aggressive transition timeline. While forward-thinking regulatory affairs professionals have initiated gap assessments and remediation plans to ensure timely compliance, a common draw back resides in leveraging corporate awareness andobtaining necessary funds to sustain the transition. Further, notified bodies must also comply with an updated set of requirements reflecting the enhanced European regulation, creating industry concern in potential orphaning, as well as the bodies’ ability to process high volumes of product re-certification within the transition time.
Following the success of the 2017 edition, and answering the needs of US-based regulatory affairs professionals, the EU MDR Implementation conference will once more delve into the new rule to clarify grey areas and common misconceptions. Taking the topics one step further, the conference will focus on the practical aspect of the regulatory transition, unveiling dependencies and how updating one regulatory strategy will impact another to ultimately build a thorough and holistic remediation strategy. Through real-life case studies presented by thought industry leaders that have launched in-house transition, as well as panel and small group discussions in addition to hands-on workshops, the event will provide participants with a high volume of key deliverables all while supplying a dynamic networking environment enabling direct interaction with peers and notified body leaders.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
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