MDR Compliance – CE Certification for Medical Devices

Achieve and Maintain EU MDR Compliance with Confidence

The European Medical Device Regulation (EU MDR 2017/745) sets a higher bar for safety, quality, and transparency. Whether you are bringing a new device to market or transitioning an existing one, achieving and maintaining MDR compliance requires an integrated approach across Quality Assurance, Regulatory Affairs, and Technical Documentation.

QbD Group helps MedTech companies navigate these complexities efficiently — combining regulatory expertise, clinical insight, and hands-on implementation support.

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Stricter regulatory oversight

Evolving interpretations and heightened Notified Body scrutiny demand greater compliance precision.

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QMS deficiencies

Gaps in Quality Management Systems can hinder certification and risk product delays.

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Higher clinical and post-market demands

Increased evidence requirements and ongoing monitoring intensify compliance workloads.

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Resource strain

Managing documentation, audits, and submissions places significant pressure on internal teams.

Quality Assurance

ISO 13485 certification does not guarantee MDR compliance
Creation or update of processes, procedures, and templates tailored to your organization
QMS gap assessments and remediation support
Development of company-specific documentation and templates
Mock audits and supplier audit leadership to prepare for Notified Body reviews

Regulatory Affairs

Define and execute a Regulatory Strategy:
- Identify products in scope
- Develop submission strategy to Notified Bodies
Set up and manage Notified Body collaboration (selection, contracting, planning)
Develop a clear Regulatory Roadmap and provide submission support
PRRC (Person Responsible for Regulatory Compliance) support
Authorized Representative services for non-EU manufacturers entering the EU market

Technical Documentation

Address all MDR requirements for your device classification
Support in generating clinical evidence and additional studies if required
Compile and review Technical Documentation ready for NB submission
Conduct gap assessments, ensure PMS/PMCF compliance, and manage remediation
Assist with risk management and usability documentation

Your road to EU MDR compliance

Our experts support you at every step, from identifying regulatory gaps to submission and certification.

Whether you are:

An EU-based manufacturer adapting to MDR, or
A non-EU company entering the European market,

QbD Group ensures compliance and accelerates your time to certification.

Get MDR support

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Why choose QbD Group?

Partner with QbD Group to confidently navigate MDR challenges and bring your devices to market faster.

With a holistic approach and hands-on expertise, we turn complex regulatory requirements into clear, actionable steps for compliance and success.

10+ years of experience supporting MedTech companies across Europe
Deep expertise in Regulatory Affairs, Clinical, and Quality disciplines
Direct collaboration with Notified Bodies and industry associations
Proven track record in successful CE marking and MDR submissions

Talk to an MDR expert

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10+ years of MedTech experience

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Regulatory, Clinical & Quality expertise

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Collaboration with Notified Bodies

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Proven MDR & CE marking success

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MDR Compliance – CE Certification for Medical Devices

Achieve and Maintain EU MDR Compliance with Confidence

The real impact of MDR compliance

Stricter regulatory oversight

QMS deficiencies

Higher clinical and post-market demands

Resource strain

How we support your MDR journey

Quality Assurance

Regulatory Affairs

Technical Documentation

Your road to EU MDR compliance

Why choose QbD Group?

10+ years of MedTech experience

Regulatory, Clinical & Quality expertise

Collaboration with Notified Bodies

Proven MDR & CE marking success

Related content

PMS & PMCF Compliance for Medical Devices Under EU MDR

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

Supporting Market Access to Essential Medicines in Europe

Medical Device Regulation (MDR) Checklist

Regulatory Affairs for Pharma and Biotech

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

Drug-Device Combination Products and Article 117

Mobile health on the rise: exploring the regulatory landscape for reimbursement

Clinical investigations under MDR: key insights and practical experiences

CE Mark Renewal for bioXtra Products: A Success Story

Technical Documentation Essentials for Medical Device Software

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Post-Market Surveillance Requirements for Medical Devices and IVDs

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

3D Printing in the Healthcare World

IVDR Extension Explained: Tips & Strategies

Innovations in ATMP: state of the industry in 2024

The journey toward IVDR compliance for the LVOne device

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Helping Relu to comply with changing regulations

Quickly bringing a new COVID-19 medical device to market

Get in touch

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