From Global Markets to MDR/IVDR
For MedTech companies from Japan, South Korea, Australia and other non-EU markets entering Europe
For Medical Device and IVD manufacturers from Japan, South Korea, Australia, and other non-EU markets, Europe represents a major growth opportunity — but also a distinct regulatory environment. PMDA, TGA, MFDS, and similar frameworks each have their own logic, while MDR and IVDR introduce different clinical, technical, and post-market expectations.
QbD Group helps non-EU manufacturers translate their existing regulatory strategies into a predictable, MDR/IVDR-compliant European pathway. From EU feasibility and gap assessment to CE marking and long-term compliance, we tailor your entry strategy to your regulatory background, clinical evidence, and commercial ambitions.
As your European partner with deep MDR, clinical, and Notified Body expertise, we help you move faster, reduce risk, and avoid costly rework.
Why Europe is challenging for non-EU MedTech companies
Even with established approvals in Japan, South Korea, Australia or other non-EU markets, your 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 your existing documentation and clinical data with EU expectations, defining tailored regulatory and clinical strategies, supporting proactive Notified Body engagement, and coordinating regulatory, quality, clinical, and post-market activities as a single European partner.
Key challenges we address
Regulatory Differences
PMDA, TGA, MFDS and similar frameworks differ from EU MDR/IVDR, requiring a tailored regulatory approach for European market entry.
Clinical Evidence Requirements
MDR and IVDR demand more extensive clinical data and performance evaluation than most non-EU jurisdictions require.
ISO/IEC Compliance
Products must meet EU-recognized standards, including ISO 13485 and related technical and quality requirements.
Notified Body Access
Limited availability of Notified Bodies and heightened scrutiny can delay submissions without proactive planning.
Mandatory EU Roles
Authorized Representative and PRRC obligations must be clearly assigned and maintained for compliance.
Fragmented Execution
Coordinating regulatory, clinical, quality, and post-market activities across Europe is complex and requires integration.
Our structured approach
Regulatory & Technical Documentation
MDR/IVDR classification, CE-marking strategy, technical file creation, GSPR, risk management, usability, and EUDAMED registration.
Clinical Strategy & Operations
CEP/CER development, PMCF planning & execution, real-world evidence, clinical trial execution (CRO role), and medical writing.
Quality Management Systems
ISO 13485 setup & optimization to MDR requirements, audit readiness, supplier quality management, and digital QMS via SciLife.
Software, AI & Digital Health
SaMD & AI-based device guidance, AI Act strategy, cybersecurity requirements, and software lifecycle documentation.
Authorized Representation & Market Entry
EU-REP, UKRP, CH-REP, importer & distributor guidance, and PRRC.
Flexible QA/RA Outsourcing
Interim regulatory roles, QA/RA specialists, and clinical & documentation support.
What you gain
Single European partner
One point of contact for all regulatory, clinical, quality, and post-market needs across Europe.
Tailored to your home market
Strategies adapted to PMDA, TGA, MFDS, and other non-EU regulatory backgrounds.
Faster time to CE mark
Proactive Notified Body engagement and gap analysis reduce delays and rework.
Why QbD Group
Your single European partner for translating non-EU regulatory experience into a predictable MDR/IVDR-compliant pathway.
Multi-market translation expertise
adapting PMDA, TGA, MFDS, and other non-EU regulatory strategies, clinical data, and documentation into EU-compliant submissions
Proactive Notified Body engagement
we prepare your technical file and clinical evidence to meet heightened EU scrutiny from day one
Integrated EU market entry services
regulatory, clinical, quality, post-market, and authorized representation under one roof
First-time-right approach
structured gap analysis and documentation strategies that reduce rework and accelerate CE marking timelines
Scalable partnership
from strategic advisory through full operational support, adapting to your project stage and ambitions
FAQ
Frequently asked questions
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 — no matter where your company is based.