MDD to MDR Transition Support

The Medical Device Regulation (MDR) isn’t just a new set of rules — it’s a new playing field. Stricter scrutiny, increased documentation, and higher expectations for clinical evidence have changed the way medical devices are brought to market in the EU.

If you're still relying on MDD approvals, now is the time to act. At QbD Group, we help medical device companies bridge the gap from MDD to MDR with expert guidance, hands-on support, and a pragmatic strategy that aligns with your product portfolio and business goals.

Whether you're navigating legacy product rules or preparing your first MDR submission, we’re here to make the transition as smooth — and successful — as possible.

Why early action is key

The shift from the MDD to the MDR is one of the most significant regulatory changes the medical device industry has faced in decades. While the MDD allowed for more flexibility, the MDR imposes more rigorous standards for safety, clinical evidence, and traceability.

Even if your products were previously CE marked under MDD, that does not guarantee compliance under MDR. Taking action early is essential to manage timelines, mitigate regulatory risk, and ensure continued access to the EU market.

Challenges manufacturers face

The MDR is much more than an update of the MDD. It’s a complete overhaul with substantial implications for your device portfolio, technical documentation, and internal processes.

Common hurdles include:

Reclassification of devices under stricter MDR rules
Lack of sufficient clinical data and justification
Notified Body capacity limitations and long lead times
Complex and time-consuming updates to technical documentation
Increased workload for QMS alignment and PMS planning
Navigating legacy and borderline product rules

Whether you're a start-up or an established manufacturer, these challenges can be overwhelming — but they’re manageable with the right guidance.

Certification backlog now exceeds 12 months

Written NB agreements needed up to 18 months ahead

No significant changes allowed during transition

MDR compliance is mandatory — no new MDD certificates issued

Quality Assurance

Your Quality Management System (QMS) must be fully aligned with MDR and ISO 13485:2016. This includes robust risk management, vigilance processes, traceability systems (UDI), and PMS procedures.

Regulatory Affairs

From device classification to conformity assessment, our experts help you define your regulatory strategy, prepare and review your documentation, and communicate effectively with Notified Bodies.

Technical Documentation

Your technical files need to be MDR-compliant — even for legacy products. That means updating your GSPRs, clinical evaluation, usability testing, biological safety, and risk-benefit justifications.

Our MDR transition approach

At QbD, we support you throughout the entire MDR transition journey. Our cross-functional team of experts works with you to design a pragmatic, step-by-step approach tailored to your specific situation.

Quality Assurance

Gap assessments & mock audits based on MDR and ISO 13485
MDR-compliant SOPs, QMS updates & documentation
Internal audits, CAPA system support & audit preparation

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Regulatory Affairs

Regulatory roadmap & classification strategy
Notified Body planning, submission coordination
Technical documentation review & remediation

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Clinical & Medical Writing

Clinical Evaluation Plans (CEP) & Clinical Evaluation Reports (CER)
PMS, PMCF planning & reporting
Writing of GSPR checklists, IFU, Risk-Benefit Justification & more

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Why partner with QbD for your MDR transition?

QbD Group is your trusted partner for all things regulatory, clinical, and quality in the medical device world.

Here’s why manufacturers choose us:

In-house expertise across QA, RA, Clinical, Biological Safety & Usability
Extensive experience with Class I, IIa, IIb, III, and legacy products
Proven methodologies for gap assessment, remediation, and CE submissions
Access to specialized tools for documentation and risk management
Agile team that scales with your needs — from guidance to full execution
Trusted by multinationals and scale-ups alike

With QbD, you don’t just get advice. You get action.

Your step-by-step path to MDR compliance

Here’s how we guide you through the MDR transition process:

Gap Assessment

We map out the gaps between your current documentation and MDR expectations — from tech files to PMS to clinical data.

1

Regulatory Strategy

We define your classification, conformity route, and Notified Body strategy based on your product portfolio.

2

Documentation Remediation

We update or rewrite your technical file sections, including GSPR checklists, risk management, clinical evaluation, and PMS plans.

3

Submission Support

We prepare your CE submission under MDR and guide you through the Notified Body review process.

4

Final CE Mark under MDR

Once compliance is confirmed, your product receives CE marking under the new regulation — ensuring continued EU market access.

5

MDR client cases: successful transitions in practice

Discover how QbD Group has successfully guided medical device companies through the complex transition from MDD to MDR, ensuring compliance and market continuity.

CE Mark Renewal for bioXtra Products: A Success Story

Challenge: Transitioning from the MDD to MDR presents significant challenges. For Lifestream Pharma, the creator and owner of the bioXtra range of products, achieving MDR compliance was a critical milestone.
Approach: QbD Group partnered with Lifestream Pharma to provide tailored support, focusing on strategic project management, regulatory expertise, and thorough documentation processes to meet MDR requirements.
Result: Through our partnership, Lifestream Pharma successfully renewed the CE mark for their bioXtra Dry Mouth products under the EU MDR, ensuring continued compliance and market presence for these well-established products.

Need support with your case? Get in touch!

Ensuring a Smooth MDR Transition for Oystershell's Medical Devices

Challenge: With the implementation of the new EU Medical Device Regulation (MDR) replacing the former Medical Device Directive (MDD), Oystershell recognized the need to proactively allocate additional resources toward compliance. This strategic focus was essential for securing or renewing the CE certificate for their medical devices, ensuring both new and existing products met the highest standards.
Approach: QbD Group's Medical Writing team, experienced in supporting clients during their MDD to MDR transition, provided tailored support by outsourcing an experienced team member to Oystershell. This ensured a seamless, efficient, and comprehensive approach to compliance and regulatory excellence.
Result: The collaboration successfully updated multiple technical files for Oystershell’s medical devices, ensuring each file contained all necessary documentation for full compliance with the MDR. This comprehensive documentation affirmed Oystershell’s commitment to adhering to regulatory standards and underscored the readiness of its products to meet the highest quality and safety benchmarks.

Need support with your case? Get in touch!

Partner with QbD Group for Your MDR Transition

Navigating the MDR landscape requires expertise and strategic planning. QbD Group is dedicated to supporting your organization through every step of the transition, ensuring compliance and market success.

MDD to MDR Transition Support

Why early action is key

Challenges manufacturers face

Certification backlog now exceeds 12 months

Written NB agreements needed up to 18 months ahead

No significant changes allowed during transition

MDR compliance is mandatory — no new MDD certificates issued

Key areas impacted in your transition from MDD to MDR

Quality Assurance

Quality Assurance

Regulatory Affairs

Regulatory Affairs

Technical Documentation

Technical Documentation

Our MDR transition approach

Quality Assurance

Regulatory Affairs

Clinical & Medical Writing

Why partner with QbD for your MDR transition?

Your step-by-step path to MDR compliance

1

2

3

4

5

MDR client cases: successful transitions in practice

CE Mark Renewal for bioXtra Products: A Success Story

Ensuring a Smooth MDR Transition for Oystershell's Medical Devices

Partner with QbD Group for Your MDR Transition

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