Overview

The transition to the In Vitro Diagnostic Regulation (IVDR 2017/746) marks a major shift for medical device manufacturers in the European market. Under the IVDR, all existing in vitro diagnostic devices must be recertified to meet new, more rigorous requirements. There are no grandfathering provisions, so understanding and implementing these changes is essential for continued market access and compliance.

This live-online training for medical device manufacturers provides a comprehensive, hands-on look at the regulation and its practical application. You will explore the requirements’ structure, timelines, and paths to CE marking, along with the significant articles and annexes that impact manufacturers most. Through expert instruction, practical examples, and interactive workshops, you will gain the knowledge and tools to navigate the transition from IVDD to IVDR with confidence.

Led by experienced instructors, this three-day course covers:

• A full overview of IVDR requirements, implementation timelines, and CE marking pathways
• Detailed discussion of key articles and annexes, including their organization and application
• Practical guidance on performing gap assessments and preparing Technical Documentation
• Understanding expanded requirements for risk management, performance evaluation, and post-market surveillance
• Comparison of IVDR requirements to ISO 13485:2016 and ISO 14971:2019 standards

Participants will engage in quizzes, hands-on exercises, and workshops focused on device classification, compliance scenarios, and real-world implementation strategies. You will also receive valuable tools, including an IVDR Gap Analysis Template, GSPR Checklist, and Technical Documentation Checklist, to support compliance within your own organization.

Recognized by Exemplar Global through their Exemplify process, this course awards a registered certificate to participants who complete all sessions, pass the quizzes, and demonstrate mastery of the workshops. By the end of this training, you will have a clear understanding of the requirements and the practical steps needed to achieve and maintain compliance. You will leave prepared to guide your organization through the transition with confidence and ensure continued access to the European market.

Included Documents

In addition to a slide presentation, activities, and quizzes, this class includes the following documents for students to utilize in their positions:

•  Copy of the IVDR
• IVDR gap analysis template
• General Safety and Performance Requirements (GSPR) checklist
• Technical Documentation Checklist

Who Should Attend

• Individuals performing audits to IVDR or Quality/Regulatory Management Systems
• Professionals guiding their organizations toward compliance
• Individuals who are frequently audited under IVDR requirements
• Quality and Regulatory Directors and Managers
• Design and Process Engineers
• Auditors and ISO Coordinators
• Laboratory Professionals
• Risk Managers
• Manufacturing Managers and Supervisors

This IVDR training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.