EU In Vitro Diagnostic Regulation Overview Training (IVDR 2017/746)

Introduction to the In Vitro Diagnostic Device Regulation (IVDR)

• IVDR entities, structure
• Overview of major changes in the IVDR

Quality Management System Requirements

• QMS roles and responsibilities in the IVDR

Exercise! Identify IVDR QMS Requirements for Manufacturers

Premarket Activities

• IVDR device classification and classification rules
• IVDR conformity assessment routes
• Technical documentation structure and content
• Role of common specifications (CS) and harmonized standards
• Technical documentation and the QMS
• Life-cycle management strategies for technical documentation

Exercise! Classify Devices

Exercise! Determine Technical Documentation Structure

Performance Evaluation

• Performance evaluation requirements
• Clinical evidence: role and sources
• Clinical performance studies under the IVDR
• Performance evaluation plan (PEP)
• Performance evaluation report (PER): inputs, content, maintenance
• Postmarket performance follow-up (PMPF) requirements

Exercise! Linking Clinical Sources, Evidence, and Benefits

Exercise! Identifying Postmarket Data Sources

Unique Device Identification (UDI)

• IVDR UDI requirements
• UDI responsibilities; impact on economic operators
• UDI electronic system and EUDAMED
• Global impact of UDI systems

Exercise! Determining UDI

Postmarket Activities

• IVDR postmarket surveillance system requirements
• Postmarket surveillance reports (PMSRs)
• Periodic safety update reports (PSURs)
• Vigilance and trend reporting
• Technical documentation and postmarket surveillance
• Role of EUDAMED in vigilance and postmarket surveillance

Exercise! Designing a Postmarket Surveillance Plan

Impact on Auditing

• IVDR requirements for Notified Bodies
• How Notified Bodies will conduct IVDR audits
• Certification process and surveillance audits
• Role of unannounced audits
• Impact of Notified Body requirements on internal audit program

Exercise! Identify Potential Nonconformities

Implementing the IVDR

• IVDR timeline
• IVDR implementation steps
• Best practices for planning and implementation

Exercise! Determine IVDR Implementation Responsibilities

Technical Documentation

• IVDR Annex I General Safety and Performance Requirements (GSPR)
• Technical documentation structure and content
• Technical documentation and the QMS roles and responsibilities in the IVDR

Exercise! Identify Impact of GSPR Requirements

Exercise! Determine Technical Documentation Structure