• There are no suggestions because the search field is empty.
Search icon
Request audit
Contact us
A realistic picture of a Chinese flag draped on the right hand side of the picture The background is a solid shade of blue-1

Your Trusted European Partner for CE Marking and MDR/IVDR Compliance

For Chinese Medical Device and IVD manufacturers with NMPA approval or regulatory experience, entering Europe requires more than familiarity with local regulations. MDR and IVDR demand strong clinical justification, high-quality technical documentation, and ongoing compliance, while Notified Bodies apply heightened scrutiny.

QbD Group helps Chinese companies translate NMPA-based strategies into MDR- and IVDR-compliant European submissions. From EU feasibility and clinical strategy to CE marking and post-market obligations, we provide local expertise to navigate EU market access with clarity, credibility, and predictability.

Talk to a European MedTech expert

Why Europe Is Challenging for Chinese MedTech Companies

Entering Europe presents specific challenges for Chinese manufacturers. Notified Bodies scrutinize clinical evidence, documentation, and post-market readiness. Data from Chinese regulatory frameworks may require EU-specific justification or studies, while language, local representation, and decentralized approval processes add complexity.

 

QbD Group acts as a European regulatory lead and execution partner, helping you:

  • Elevate documentation to EU quality standards

  • Design EU-relevant clinical evidence strategies

  • Manage proactive Notified Body interactions

  • Coordinate mandatory EU roles

See the challenges
Why Europe Is Challenging for Chinese MedTech Companies

 

Challenges When Bringing a Medical Device to Europe

Europe offers strong commercial opportunities, but non-EU manufacturers often encounter complex regulatory and operational hurdles. Chinese companies face specific challenges that require expert guidance:

Balance

Regulatory Differences

NMPA logic differs from EU MDR/IVDR, requiring tailored regulatory strategies for successful market entry.

Labs

Clinical Evidence Requirements

MDR and IVDR demand more extensive clinical data than domestic requirements, including EU-specific studies or justifications.
checklist_rtl

ISO/IEC Compliance

Products must meet EU-recognized standards such as ISO 13485 and related technical and quality requirements.
search

Notified Body Access

Limited availability and heightened scrutiny from Notified Bodies can delay submissions without proactive planning.
Person

Mandatory EU Roles

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

Autorenew

Fragmented Execution

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

 

Accelerate Your Market Entry into Europe - QbD Group-1-1

Your EU Journey as a Chinese Company

Many Chinese MedTech manufacturers start on the Starting EU Entry pathway and may need EU-specific clinical investigations. QbD supports feasibility, QMS setup, technical documentation, clinical trials, Notified Body submission, CE marking, and ongoing PMS, PMCF, and vigilance, delivering a clear and predictable path to European market access.

Start your EU journey

 

Our Specialized MedTech Services for Chinese 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.

edit_document

Regulatory & Technical Documentation

  • MDR/IVDR classification

  • CE-marking strategy

  • Technical file creation

  • GSPR, risk management, usability

  • EUDAMED registration

Stethoscope

Clinical Strategy & Operations

  • CEP/CER development

  • PMCF planning & execution

  • Real-world evidence

  • Clinical trial execution (CRO role)

  • Medical writing

assignment_turned_in

Quality Management Systems

  • ISO 13485 setup & optimization to MDR requirements

  • Audit readiness

  • Supplier quality management

  • Digital QMS via SciLife

robot_2

Software, AI & Digital Health

  • SaMD & AI-based device guidance

  • AI Act strategy

  • Cybersecurity requirements

  • Software lifecycle documentation

Person

Authorized Representation & Market Entry

  • EU-REP, UKRP, CH-REP

  • Importer & distributor guidance

  • PRRC

Autorenew

Flexible QA/RA Outsourcing

  • Interim regulatory roles

  • QA/RA specialists

  • Clinical & documentation support

 

contact-mail

Talk to a EU MedTech Expert

Complete the form, and our team will help you translate NMPA experience into MDR/IVDR-compliant submissions, design EU-specific clinical strategies, and guide your product through CE marking and post-market obligations for a smooth European entry.

Contact_form