Preparing for Your First IVDR Notified Body Audit

Notified Body audits under IVDR are more comprehensive than under the previous directive. This guide helps you prepare effectively for your first certification audit.

Understanding the Audit Scope

IVDR Notified Body assessments typically cover:

• Quality Management System (ISO 13485 compliance)
• Technical Documentation review
• Manufacturing site assessment
• Post-market surveillance systems

Common Audit Findings

Based on industry experience, frequent non-conformities include:

• Incomplete traceability between design inputs and outputs
• Insufficient evidence in performance evaluation reports
• Gaps in risk management file documentation
• Inadequate post-market surveillance planning
• Missing or incomplete GSPR compliance evidence

Documentation Preparation Tips

Ensure your technical documentation is:

• Complete and internally consistent
• Properly version controlled
• Cross-referenced where applicable
• Accessible and organized for auditor review

QMS Readiness

Verify that your QMS procedures address all IVDR-specific requirements, including those related to UDI, economic operators, and vigilance reporting.

Staff Preparation

Ensure key personnel understand their roles and can articulate how your processes meet regulatory requirements. Consider conducting internal mock audits to identify gaps.