IVDR Transition Support
Navigate the IVDD to IVDR transition with confidence
With average certification timelines ranging from 13–18 months and transition deadlines fast approaching, IVD manufacturers can't afford to wait. Planning early ensures compliance and gives you a competitive edge.
Why early action is key
With average certification timelines ranging from 13–18 months and transition deadlines fast approaching, IVD manufacturers can't afford to wait. Planning early not only ensures compliance—it gives you a competitive edge.
Without a clear plan, adequate resources, and compliant documentation, even well-established organizations risk falling behind.
Our IVDR transition approach
We support you from initial assessment to final submission. Whether you're reworking your QMS, compiling your STED file, or need Notified Body coordination, we're here to guide the process from A to Z.
Gap assessment
Comprehensive gap assessment and mock audits to identify areas needing attention.
QMS updates
IVDR-compliant SOPs and Quality Management System updates.
Regulatory roadmap
Clear regulatory roadmap including NB selection, planning, and submission strategy.
Documentation support
Technical documentation, STED compilation, and submission support.
Key areas impacted
The transition from IVDD to IVDR impacts multiple areas of your organization:
Quality Assurance
ISO 13485 certificate does not guarantee IVDR compliance. Create/update processes, procedures, templates.
Regulatory Affairs
Define regulatory strategy, products in scope, and submission strategy to Notified Bodies.
Technical Documentation
New IVDR requirements need to be addressed. Compile STED ready for NB review.
Clinical & Medical Writing
Performance evaluation plans & studies. Scientific validity & analytical performance.
Why QbD Group
Your trusted partner
We combine deep regulatory expertise with hands-on industry experience to help you meet IVDR requirements.
Proven track record in successful IVDR transitions.
End-to-end support from gap assessment through NB submission.
Cross-functional expertise: QA, RA, Technical Documentation, and Clinical.
Direct experience with major European Notified Bodies.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.