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From FDA to MDR: Your European Market Entry, Simplified

For US Medical Device and digital health companies with FDA clearance or regulatory experience, Europe is a natural next step. MDR and IVDR, however, introduce a different regulatory, clinical, and post-market reality.

QbD Group helps US manufacturers translate FDA-based strategies into a predictable, MDR-compliant European pathway. We guide you from EU feasibility and gap assessment through CE marking and long-term compliance.

As your European partner with deep MDR, clinical, and Notified Body expertise, we help you move faster, reduce risk, and avoid costly rework.

Talk to a European MedTech expert

Why Europe Is Challenging for US MedTech Companies

Even with FDA clearance, US products don’t automatically meet MDR/IVDR requirements. Clinical evidence expectations differ, post-market obligations such as PMCF and vigilance are ongoing, and regulatory approval is decentralized via Notified Bodies.

 

QbD Group bridges this gap by:

  • Aligning FDA-based documentation and clinical data with EU expectations.

  • Defining early regulatory and clinical strategies.

  • Supporting proactive Notified Body engagement.

  • Coordinating regulatory, quality, clinical, and post-market activities as a single European partner.

See the challenges
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Key Challenges for US MedTech in Europe

Despite its commercial opportunity, Europe remains a complex and often underestimated market for non‑EU MedTech manufacturers. US companies commonly face:

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Regulatory Differences

US FDA logic differs from EU MDR/IVDR requirements, requiring a tailored regulatory approach for European market entry.

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Clinical Evidence Requirements

MDR and IVDR demand more extensive clinical data and performance evaluation than FDA alone.
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ISO/IEC Compliance

Products must meet EU-recognized standards, including ISO 13485 and related technical and quality requirements.
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Notified Body Access

Limited availability of Notified Bodies and heightened scrutiny can delay submissions without proactive planning.
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Mandatory EU Roles

Authorized Representative and PRRC obligations must be clearly assigned and maintained for compliance.

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Fragmented Execution

Coordinating regulatory, clinical, quality, and post-market activities across Europe is complex and requires integration.

 

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Your EU Journey as a US Company

Most US MedTech companies follow the 'Ready for the EU Market' pathway, but success requires expert coordination. QbD Group guides you every step of the way:

    • EU landscape and gap assessment,

    • alignment of quality and technical documentation,

    • MDR-compliant clinical strategy,

    • Notified Body engagement and submission,

    • CE marking,

    • and ongoing post-market surveillance and vigilance.

Start your EU journey

 

Our Specialized MedTech Services for US Companies

Bringing a US MedTech product to Europe requires expertise across multiple disciplines. QbD Group offers specialized services tailored to US companies, helping you navigate regulatory, clinical, quality, and post-market requirements with confidence and efficiency.

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Regulatory & Technical Documentation

  • MDR/IVDR classification

  • CE-marking strategy

  • Technical file creation

  • GSPR, risk management, usability

  • EUDAMED registration

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Clinical Strategy & Operations

  • CEP/CER development

  • PMCF planning & execution

  • Real-world evidence

  • Clinical trial execution (CRO role)

  • Medical writing

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Quality Management Systems

  • ISO 13485 setup & optimization to MDR requirements

  • Audit readiness

  • Supplier quality management

  • Digital QMS via SciLife

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Software, AI & Digital Health

  • SaMD & AI-based device guidance

  • AI Act strategy

  • Cybersecurity requirements

  • Software lifecycle documentation

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Authorized Representation & Market Entry

  • EU-REP, UKRP, CH-REP

  • Importer & distributor guidance

  • PRRC

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Flexible QA/RA Outsourcing

  • Interim regulatory roles

  • QA/RA specialists

  • Clinical & documentation support

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Talk to a EU MedTech Expert

Fill out the form, and our team will guide you on regulatory strategy, clinical evidence, CE marking, and quality alignment to ensure a smooth European market entry.

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