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In vitro diagnostics
IVDD to IVDR Transition Support | IVD Compliance Experts | QbD Group

IVDD to IVDR Transition Support

Making the transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) can seem daunting—especially for manufacturers and suppliers working across Tanzania or East Africa. But with the right regulatory guidance, this shift becomes more than just a challenge—it becomes an opportunity to strengthen your product’s safety, performance, and international market readiness.

At Labmark, we understand both the regional regulatory landscape (including TMDA) and the global compliance demands of IVDR. Whether you're exporting to the EU or aligning with international donor-funded programs, our experts are ready to guide you every step of the way—from strategic planning to technical documentation refinement.

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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.

 

Challenges manufacturers face

 

Understanding the urgency is only the first step.

As deadlines approach, many IVD manufacturers find themselves unprepared — not because they lack intention, but because they underestimate the complexity of the transition.

Without a clear plan, adequate resources, and compliant documentation, even well-established organizations risk falling behind.

Certification delays now exceed 1 year in some cases

Written NB agreements required 2 years in advance

No significant changes allowed during transition

QMS must be IVDR-compliant by May 2025

Key areas impacted in your transition from IVDD to IVDR?

Quality Assurance

Quality Assurance

  • ISO 13485 certificate does not guarantee IVDR compliance
  • Create/update processes, procedures, templates

 

 

 

Regulatory Affairs

Regulatory Affairs

  • Define Regulatory Strategy:
    • Define products in
      scope of transition
    • Define strategy
      for submission to NB
  • Setting up collaboration with Notified Bodies (selection, contracting, planning)

Technical Documentation

Technical Documentation

  • New IVDR requirements need to be addressed
  • Additional Clinical Evidence Activities
  • Compile Summary of Technical Documentation (STED) ready
    for NB review

 

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.
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Quality Assurance

  • Gap assessment & mock audits
  • IVDR-compliant SOPs and QMS updates
  • Custom documentation & procedures
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Regulatory Affairs

  • Regulatory roadmap & product scoping
  • NB selection, planning & submission strategy
  • Technical Documentation & submission support
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Clinical & Medical Writing

  • Performance evaluation plans & studies
  • Scientific validity & analytical performance
  • Writing of STED, PER, PEP, LRP, and more
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IVDD to IVDR Transition Support | IVD Compliance Experts

Why partner with Labmark for your IVDR transition?

  • East Africa + EU Regulatory Insight
    We speak both “languages”—deep knowledge of Tanzanian compliance and international regulations..
  • Tailored Transition Plans
    We don’t use one-size-fits-all models. Your roadmap is customized to your internal capacity, documentation maturity, and timelines.
  • End-to-End Expertise
    From QA and RA to clinical evaluation and technical writing—we have the local and international specialists you need.
  • Recognized by Notified Bodies
    BSI and GMED recommend expert-reviewed documentation—QbD is that expert.
  • Accelerated Compliance
    Reduce your prep time by 50% with our focused, structured approach.
  • Trusted Partnerships
    We work in tandem with your team or your EU Authorized Representative to ensure smooth coordination and successful submission to Notified Bodies (e.g., BSI, TÜV SÜD).
Contact us today
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Your step-by-step path to IVDR compliance

 

Navigating the IVDD to IVDR transition doesn’t have to be overwhelming. Our structured 8-step approach guides you from initial scoping to final submission, ensuring every requirement is met with clarity, quality, and confidence.

Project scoping & kick-off
Define the project scope and assemble a multidisciplinary team with a dedicated project manager.

1

Regulatory Strategy
Qualify and classify devices under IVDR and ensure alignment with PMS and PMPF requirements.

2

Gap Assessment
Review technical documentation and assess your QMS and clinical evidence for IVDR readiness.

3

Transition Strategy
Build a roadmap to close gaps in QMS, technical documentation, and clinical requirements.

4

Change Management
Train all relevant teams to align internal processes with IVDR obligations.

5

Remediation Strategy
Address documentation gaps, update procedures, and implement an IVDR-compliant QMS.

6

Mock Audit / Assessment
Conduct internal audits and review documentation to confirm IVDR compliance.

7

Submission
Submit your QMS and technical documentation for formal IVDR assessment.

8