Interpreting & Implementing Changes to Conformity Assessments in-line with IVDR Reclassification Requirements, Current Status of NB Re-designation and IVD Certification Process, Methodologies for Gap Analysis of Technical Files & Documentation, and Fundamentals of Post-Market Surveillance & Vigilance Under the IVDR
With the release of the European In Vitro Diagnostic Regulation (IVDR) in May of 2017, the five-year transition countdown to enact updated regulatory strategies began for IVD manufacturing corporations, notified bodies and EU regulators alike. As the EU IVDR will supersede the current directives, and introduces many new requirements, it is pivotal for the industry to gain a strong understanding of mandates, as well as a full perspective of the impact on all operations, to establish a comprehensive and aggressive transition timeline. While many regulatory professionals have initiated gap assessments and remediation plans to ensure timely compliance, a common concern resides in leveraging corporate awareness and obtaining 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.
This program is eligible for up to 6.0 RAC credits. A certificate of attendance and final digital copy of the agenda will be provided to all attendees upon request. For further details regarding the submission process for RAC credits, please visit: https://q1productions.com/raps-credit/
Lydia Welmer | Marketing Coordinator | Q1 Productions
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