IVDD to IVDR Transition Support

Making the leap from IVDD to IVDR can feel overwhelming—but it doesn’t have to be. With the right guidance, this regulatory shift is more than a hurdle; it’s an opportunity to elevate your in vitro diagnostic devices to the highest standards of safety, performance, and market readiness.

At QbD Group, we combine deep regulatory expertise with hands-on industry experience to help you meet IVDR requirements efficiently and strategically. Whether you're just starting your transition or fine-tuning your technical documentation, our experts are here to support every step — so you stay compliant, confident, and competitive.

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

Quality Assurance

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

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

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.

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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Why partner with QbD for your IVDR transition?

End-to-end IVD expertise
QA, RA, Clinical, and Medical Writing—fully covered by senior specialists.
Tailor-made transition plans
Roadmaps aligned with your portfolio, internal capacity, and timelines.
Proven success across 100+ submissions
We've written over 100 IVDR Technical Documentations since 2018.
Recognized by Notified Bodies
BSI and GMED recommend expert-reviewed documentation—QbD is that expert.
Accelerated time-to-submission
Reduce your prep time by 25–50% with our focused, structured approach.
Hands-on, pragmatic support
From kick-off to submission, we guide and coordinate every step of the way.

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

IVDR client cases: successful transitions in practice

From small-scale innovators to large manufacturers, our IVDR clients trust QbD to guide them through complex transitions with clarity and confidence. Explore how we’ve helped companies streamline documentation, reduce timelines, and achieve compliance—on time and with quality recognized by Notified Bodies.

Large-scale Transition – 48 Class C Devices

Supported a full IVDR transition for 48 Class C products within the same generic device group.
Assigned 8 senior consultants and ~1.5 FTE for strategy, documentation, and submission.
Used a phased submission strategy—first certification achieved in just 12 months.
Complete IVDR certification of all products finalized within 22 months.

Need support with your case? Get in touch!

Small Oncology Company – NGS & Software

Assisted a small-scale company in transitioning NGS-based IVDs combined with software.
Completed QMS and documentation gap assessment in Q4 2023.
Provided full remediation, including clinical evidence, usability, and STED creation.
Submission support planned from March 2025, with a 5-member expert team.

Need support with your case? Get in touch!

IVDD to IVDR Transition Support

Why early action is key

Challenges manufacturers face

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

Regulatory Affairs

Regulatory Affairs

Technical Documentation

Technical Documentation

Our IVDR transition approach

Quality Assurance

Regulatory Affairs

Clinical & Medical Writing

Why partner with QbD for your IVDR transition?

Your step-by-step path to IVDR compliance

1

2

3

4

5

6

7

8

IVDR client cases: successful transitions in practice

Large-scale Transition – 48 Class C Devices

Small Oncology Company – NGS & Software

Start your IVDR transition today

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