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VIRTUAL WORKSHOP SERIES

EU-MEDICAL DEVICE REGULATION AND IN VITRO DIAGNOSTICS REGULATION COMPLIANCE

Presented by FDAnews and Ombu Enterprises

Agenda

All sessions are held from 10:00 a.m. - 4:30 p.m. ET


Tuesday, Nov. 10, 2020: Auditing EU-MDR and EU-IVDR Implementation

10:00 a.m. - 11:00 a.m.
The Internal Audit Program
  • ISO 19011:2018
  • ISO 13485:2016
  • Planning, conducting and reporting
11:00 a.m. - 12:30 p.m.
Conformity Assessment Paths

Device Specific Areas
  • QMS and risk management system (RMS)
  • The Annex I documentation
  • The Annex II and Annex III documentation
12:30 p.m. - 1:30 p.m.
Break

1:30 p.m. - 2:45 p.m.
The Application to the NB

The NB Approach to the Audit

2:45 p.m. - 3:00 p.m.
Break

3:00 p.m. - 4:30 p.m.
Integrating NB Approach with Internal Audits
  • Conducting a mock audit

Session 1 (Recorded Tuesday, Sept. 29, 2020): EU-MDR Implementation

Available in the workshop recording archive.

Overview and Article 120
  • MDR timeline
  • Article 120
  • Standards and harmonization
  • Medical device coordination group (MDCG) guidance documents
Quality Management System (QMS) Implementation
  • Article 10(9) requirements
  • Other traditional QMS elements
Break

Device Implementation
  • Annex VIII device classification
  • Article 52 conformity assessment
  • Annex I evaluation
  • Annex II documentation
  • Annex III documentation
Break

Notified Body (NB) Interaction
  • Conformity assessment application
  • NB technical document review
  • NB on-site audit

Session 2 (Recorded Tuesday, Oct. 27, 2020): EU-IVDR Implementation

Available in the workshop recording archive.

Overview and Article 110
  • In vitro diagnostics regulation (IVDR) timeline
  • Article 110
  • Standards and harmonization
  • MDCG guidance documents
QMS Implementation
  • Article 10(8) requirements
  • Other traditional QMS elements
Break

Device Implementation
  • Annex VIII device classification
  • Article 48 conformity assessment
  • Annex I evaluation
  • Annex II documentation
  • Annex III documentation
Break

NB Interaction
  • Conformity assessment application
  • NB technical document review
  • NB on-site audit

Session 3 (Recorded Wednesday, Nov. 4, 2020): Post-Market Activities for the EU-MDR and EU-IVDR

Available in the workshop recording archive.

Pre-market Considerations
  • The role of pre-market activities
  • Clinical evaluation (plan and report)
  • Clinical performance (plan and report)
  • Risk management (plan, file and report)
  • Benefit-risk determination
  • Indicators and thresholds
Market Surveillance

Post-market Surveillance

Post-market Clinical Follow-up

Break

Post-market Performance Follow-up

Summary of Safety and Clinical Performance (SSCP)

Break

Vigilance and Trend Analysis

Statistically Significant Increase
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