征服MDR迷宫：专家洞察和真实世界的例子.pdf

1、Sponsored byEhab Esmail,OrthofixMatthias Fink,M.D.,AKRA Team Sandeep Ramineni,Ph.D.,TV SD(slides not available)Conquer the MDR Maze:Expert Insights&Real-World ExamplesConquer the MDR Maze:Expert Insights&Real-World ExamplesEhab EsmailSenior Vice PresidentGlobal Quality,Regulatory and Clinical Affair

2、sPresidentBoard MemberAGENDAMDR Requirements Remediation?Equivalence Medical DevicesSignificant Change vs.Substantial ChangeFDA vs.CE MarkPerson Responsible for Regulatory Compliance(PRRC)1.Gap Analysis and Project PlanningProject Management2.Enhanced Clinical EvidenceClinical ResearchPost-Market Su

3、rveillance3.Technical Documentation UpdateProduct Development Quality Assurance4.UDI Implementation and EUDAMED RegistrationOperations and Manufacturing IT Systems 5.Reclassification of DevicesProduct Development 6.Quality Management System(QMS)UpdateQuality Assurance 7.Supply Chain and Economic Ope

4、rators ComplianceOperations and ManufacturingSales and Marketing&Transportation and Logistics8.Risk Management and Post-Market Activities EnhancementProduct Development&Risk Management:Post-Market Surveillance9.Training and AwarenessAll Functions10.Notified Body Interaction-LeadershipQuality Assuran

5、ceMDR RequirementsRemediations?EquivalenceMedical DevicesEU-MDR Equivalence Pathway-Clinical,Biological and Technical-Access to Competitor DocumentationFDA 510(k)Pathway-Substantial equivalence less stringent-Premarket Approval(PMA)-De NovoSignificant Changevs.Substantial ChangeChart A Intended purp

6、ose changesChart B Design changesChart C Software changesChart D Material or substance/ingredient changesChart E Sterilization changesFDA vs.CE MarkRequirements?Cost?Time?In summaryWhat is the true impact on industry?Legacy devices(Design Controls?)Clinical(Data Collection?)Product obsolescence(Time