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Complimentary Webinars

March 30, April 6, 13, 20 & 27, 2021 |

12:00 p.m. - 2:30 pm EDT

Innovation in Practice Virtual Event

March 30 - April 27, 2021

The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios.  Preparation will involve strategic thinking and buy-in at the highest levels.

Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred.  For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market.

Who Should Attend:

Diagnostics company professionals in:

·      Management
·      RA/QA
·      Clinical
·      Risk management
·      Postmarket surveillance
·      Labeling
·      Compliance / Auditing
·      Legal
·      International affairs
·      Policy
·      Supply Chain
·      Global strategy
·      Product management
·      Project management

 

March 30, 2021

EU IVDR Introduction

The reclassification of diagnostics under EU IVDR means that many companies, particularly those with previously self-certified products, face tremendous new challenges in complying with strict regulations and working with notified bodies.  This introductory webinar provides an overview, timeline, new classification system, and procedures for working with notified bodies.

Topics to be addressed include:

  • Overview of key differences between the IVD Directive (IVDD) and Regulation (IVDR)
  • Expanded applicability to include 80% of manufacturers Implementation timeline
  • The new classification procedure for diagnostics Conformity assessment routes
  • The impact on legacy and future products and company business models
  • The need for notified body participationProcedures for working with a notified body

Register Here for Week 1: EU IVDR Introduction


 

April 6, 2021

Quality Processes and Documentation

EU IVDR requirements demand significant changes in company quality procedures, management oversight, risk assessment, and documentation.  This session outlines major changes, their impact, and strategies for implementation.

Topics to be addressed include:

  • New quality system requirements
  • Increased management responsibility
  • Designation of a person responsible for regulatory compliance (PRRC)
  • Change from a list-based to risk-based approach
  • Risk-based reclassification of all tests
  • The relationship between IVDR risk requirements and ISO 14971 and 13485
  • Establishing new relationships between risk management, clinical evaluation, and postmarket activities and reports
  • Need for redesign of quality procedures, IT systems, and technical files across the organization
  • Technical file formats

Register here for Week 2: Quality Processes and Documentation


 

Episode Sponsored by:

April 13, 2021

Clinical Evidence & Surveillance

The most demanding requirements imposed by EU IVDR concern clinical and performance evaluation, even of legacy products, and stringent ongoing postmarket assessments.  Some confusion remains about procedures and expectations, and our speakers discuss best approaches and strategies. 

Topics to be addressed include:

  • Performance evaluation to show scientific validity, analytical performance, and clinical performance
  • Sufficient clinical evidence
  • Demonstrating clinical utility
  • Postmarket surveillance plan to monitor key safety, performance, and risk elements
  • Postmarket performance follow-up studies (PMPF)
  • Periodic safety updates and clinical evaluation throughout the product lifetime Incident reporting and trending

Register here for Week 3: Clinical Evidence & Surveillance


 

April 20, 2021

Supply Chain Management: Economic Operators, UDI, and Labeling

EU IVDR requires substantial and challenging changes in relationships with suppliers, distributors, and other economic operators, as well as changes to all labeling and new traceability requirements.  These can be some of the most costly and troublesome aspects of EU IVDR, and companies should plan quickly and carefully.

Topics to be addressed include:

  • Why the new emphasis on supply chain and economic operators?
  • Mapping the supply chain
  • Definitions and responsibilities of economic operators
  • Contractual agreements with economic operators
  • Assessment of systems for evaluating, monitoring and documenting suppler performance and providing greater traceability and transparency
  • Compliance, verification, and reporting issues
  • New labeling and IFU requirements
  • Traceability, UDI, and reporting requirements 
  • EUDAMED 

Register here for Week 4: Supply Chain Management - Economic Operators, UDI, and Labeling


 

April 27, 2021

Strategy and Planning

EU IVDR implementation is not merely a question of changing a few SOPs.  It requires a portfolio review of legacy products and substantial changes from the top down in organizational structure and processes.  Learn from experts who have already gone through IVDR implementation, know where the greatest costs and stumbling blocks lie, and offer strategies for effective project management.

Topics to be addressed include:

  • Project management developing an enterprise-wide cross-functional approach
  • Gap analysis on individual products and portfolio review and global market impact analysis
  • Creating new systems for EU IVDR implementation and ongoing management of data development and reporting
  • Resource requirements and the cost of compliance

Register here for Week 5: Strategy and Planning

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