Medical Device Regulatory
At Accumed, we are committed to supporting manufacturers and distributors in navigating the complex regulatory landscape for medical devices across Europe. Whether you are entering the Swiss, European Union (EU), or United Kingdom (UK) markets, understanding and fulfilling local regulatory obligations is essential for legal distribution and patient safety.
REGULATORY
Why an Authorized Representative matters?
In today’s fragmented regulatory landscape, manufacturers outside Switzerland, the EU, or the UK must appoint a local Authorized Representative (AR) to legally place medical devices on these markets.
This requirement stems from:
Swiss MedDO & IvDO
Non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP) to interact with Swissmedic and ensure compliance
EU MDR & IVDR
Non-EU manufacturers must designate an EU Authorized Representative (EU-REP) to fulfill obligations under Regulation (EU) 2017/745 and 2017/74
UK MHRA
Post-Brexit, non-UK manufacturers must appoint a UK Responsible Person (UKRP) to manage UKCA registration and compliance
REGULATORY
Why Accumed as your Authorized Representative?
At Accumed, we combine regulatory expertise with hands-on commercial experience.
Having worked extensively in Sales & Marketing within the medical device sector, we understand the urgency of entering the market without unnecessary delays.
Fast Onboarding & Modular Services
Rapid onboarding and scalable service packages tailored to startups, SMEs, and global manufacturers.
Strategic Consulting & Business Alignment
Help clients align compliance with go-to-market strategies, product launches, and lifecycle planning.
Multi-Jurisdictional Representation
Act as CH-REP, EU-REP, and UKRP, streamlining compliance across borders and reducing administrative burden for clients.
Technical Documentation & Vigilance
Expertise ensures that manufacturers avoid costly delays, non-conformities, or recalls.
Authority Liaison & Incident Management
Deep regulatory knowledge and experience handling audits, complaints, and field safety corrective actions.
Regulatory Mastery Across Jurisdictions
Understand the regulations and how they evolve, interact, and impact manufacturers
Our Approach
1
Mandate & Onboarding
- Sign a formal mandate agreement outlining responsibilities and scope.
- Collect and review the manufacturer’s technical documentation.
- Verify device classification, intended use, and regulatory status.
- Register the mandate with the relevant authority (e.g., Swissmedic, EUDAMED, MHRA).
2
Regulatory Oversight & Representation
- Maintain and make available the technical documentation for inspection.
- Monitor regulatory updates and inform the manufacturer of changes.
- Support incident reporting, vigilance, and corrective actions.
- Ensure labeling and language requirements are met for the local market.
3
Lifecycle Support & Communication
- Coordinate post-market surveillance and periodic updates.
- Respond to authority inquiries and audits.
- Support renewals, modifications, or withdrawals of device registrations.
- Keep records of complaints, field safety notices, and recalls.
Have a question or want to learn more about our services? Don't hesitate to contact us!