Enter the European market with confidence in compliance.
EU Authorized Representative & Regulatory Services — supporting Japanese medical device manufacturers from Belgium
Book a free consultationChallenges on the road to Europe
MDR and regulatory hurdles
- Complex CE marking process
- Extensive Notified Body communication and documentation
- Unclear post-market surveillance requirements
No EU base or single contact point
- A legal representative in the EU is required
- Coordinating multiple vendors is a burden
- Uncertainty in dealing with authorities
What DS4EU delivers
A hands-on EU MDR partner you can consult in Japanese
End-to-end support from pre-clinical to post-CE
AR, QMS and investigational device logistics from one company
A single point of contact at every stage of EU market entry
Support model
DS4EU is always your single contact point — zero multi-vendor coordination burden.
Services
Regulatory Services
From MDR strategy and gap analysis to technical documentation — we design your path to CE marking.
Clinical Investigation Support
From Legal Representative services for non-EU sponsors to submission preparation and ethics committees — we support your EU clinical investigation end to end.
EU Authorized Representative (AR)
From AR registration to technical file custody and authority liaison — your Article 11 MDR obligations covered under an annual agreement.
QMS Services
From MDR gap analysis to SOP review, internal audits and CAPA — continuous support for MDR-compliant quality management.
Why DS4EU
Deep understanding of Japanese companies
- Full Japanese-language support
- Fluent in Japanese quality culture
- Fast and careful communication
European regulatory expertise
- MDR strategy
- Clinical investigation support
- AR, QMS and post-market obligations
Start with a free 30-minute consultation
We help you map your current position: device class, CE status, and EU clinical investigation plans.
Book a free consultation