3 Day Schedule: 7:30 AM- 4:30 PM MST CEU Hours: 2.5 Audience: Beginner to Advanced

The European Regulation 2017/746 related to In Vitro Diagnostic Devices (IVDR) is in effect and companies must make the transition!

Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation. 

Overview

A three-day course on the In Vitro Diagnostic Regulation 2017/746 with a focus on the requirements for Medical Device Manufacturers.

In this course, you will receive a general overview of the IVDR, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.

Included in the presentation is a copy of the IVDR, an IVDR gap analysis template, a General Safety and Performance Requirements (GSPR) checklist, and a Technical Documentation Checklist.

Who Should Attend

Individuals who will perform audits to IVDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward IVDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.

Objectives

• Outline the primary changes that need to be addressed to Transition from IVDD compliance to IVDR compliance
• Practical guidance on how to address the new IVDR requirements
• Describe/Understand the objectives, terminology and structure of the IVDR.
• Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier
• Explain the impact of the new IVDR requirements on economic operators (importers, authorized representatives) including manufacturers.
• Describe the different regulatory requirements through lifecycle of device, e.g. proof of concept, design and development, clinical evaluation, regulatory approval, manufacturing, postmarket/vigilance & end of life.
• Describe the increased requirements for risk management including risk benefit and state of the art
• Plan a gap assessment to transition an organization to compliance.
• Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist)
• Identify the necessary step as to prepare an organization to transition to the IVDR.

Agenda

• High level overview of the EU IVD Regulation
  1. Definitions
  2. Primary changes in the regulation and how to address them
• Implementation timeline
• Review of the 113 MDR Articles, the organization of the regulation and “how to find things”
• Paths to CE Mark
• Review of the 14 Annexes, their structure and “how to find things”
• Lifecycle of a Medical Device and related Articles and Annex requirements
  1. Proof of Concept
  2. Design & Development
  3. Device Classification
  4. Design and Safety Requirements
  5. Risk Management
  6. Performance Evaluations
  7. Performance Studies
  8. Manufacturing requirements
     1. UDI requirements
  9. Conformity Assessments – Class A, B, C, D
  10. Technical Documentation
  11. Conformity Paths for – Class A, B, C, D
  12. Registration of Devices and Placing on the Market
  13. Post Market Surveillance and Vigilance
• Review of Significant Articles
  1. In Depth Review and Discussion of Articles
• Review of Significant Annexes
  1. In Depth Review and Discussion of Annexes
• Strategy for Deployment
• Significant Pitfalls to watch out for
• Unknowns – Still to be determined
• Tools and References

Quizzes, Tools, Workshops: Each day are ongoing quizzes to confirm your understanding of key concepts;  Review of helpful tools including:  EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14971:2019 checklist and comparison to the MDR requirements;  Further, there are workshops including:  Device Classification, Compliance Scenarios, and review of practical implementation examples.

This class is certified by Exemplar Global under their Exemplify process.  Accordingly, all students who attend the entire class, pass the quizzes, and demonstrate mastery of the workshops will receive a registered Certificate recognized by Exemplar Global.