European Authorized Representative (EC-REP)
Under EU MDR 2017/745 and IVDR 2017/746, manufacturers outside the EU must appoint a European Authorized Representative. We deliver the full mandate — from the agreement and EUDAMED registration to ongoing post-market compliance.
Why Do You Need a European Authorized Representative?
Under Article 11 of EU MDR 2017/745 and Article 11 of EU IVDR 2017/746, a manufacturer without a registered place of business in the EU must designate, by written mandate, a European Authorized Representative (EC-REP) before placing devices on the EU market.
The EC-REP is the legal point of contact between the manufacturer and the competent authorities of the Member States: registration checks, document availability, vigilance communication and field safety corrective action (FSCA) coordination all run through the representative. Products without a representative may be detained at the border, and Notified Bodies will not proceed with CE certification.
- Applies to all MDR risk classes and all IVDR in-vitro diagnostics
- The representative's name and address must appear on the label, packaging and instructions for use (EC-REP indication)
- Both manufacturer and representative must register in EUDAMED and obtain an SRN
Regulatory Basis
Our EC-REP services follow the current EU regulatory framework.
Medical Device Regulation · Article 11
Non-EU manufacturers must designate an authorised representative, with defined duties, document-retention obligations and joint liability. Article 15 additionally requires a person responsible for regulatory compliance (PRRC).
In-Vitro Diagnostic Regulation · Article 11
IVD manufacturers face the same authorised-representative requirements. Class D devices and performance-study matters all require representative coordination.
European Database on Medical Devices
Economic operators (manufacturers, representatives, importers) must register and obtain an SRN. We assist with role registration, LAA/LUA setup and device/UDI data entry.
Vigilance & Post-Market Surveillance
Serious incidents within 15 days (10 days for death or serious deterioration, 2 days for serious public-health threats), FSCA/FSN coordination, PMS and PMCF support.
Our Services
Full-lifecycle EC-REP coverage, from pre-contract assessment to ongoing post-market maintenance.
Representation Agreement & Mandate
Bilingual authorized-representative agreement defining the scope of mandate, document retention, liability boundaries and termination terms, compliant with MDR/IVDR written-mandate requirements.
EUDAMED Registration & SRN
Complete the representative's economic-operator registration and obtain its SRN; assist the manufacturer with EU Login, LAA/LUA setup and device & UDI registration.
Label & IFU Review
Review the representative's name and address on labels, packaging and instructions for use, plus UDI carriers and regulatory symbols — compliant before market placement.
PRRC Support
Per MDR/IVDR Article 15, help manufacturers put in place the Person Responsible for Regulatory Compliance (PRRC) — designation options and qualification requirements.
Incident Reporting & FSCA Coordination
Help determine reportable incidents, submit serious-incident reports to competent authorities within statutory deadlines, and coordinate field safety corrective actions (FSCA) and field safety notices (FSN).
Certificates of Free Sale (FSC)
Assist manufacturers in obtaining EU Certificates of Free Sale for registrations and tenders outside the EU (Middle East, Southeast Asia and beyond).
Competent-Authority Communication
As the legal point of contact, receive and relay enquiries, inspection notices and compliance requests from competent authorities and Notified Bodies — with bilingual support throughout.
Post-Market Surveillance (PMS) Support
Help establish PMS plans, Periodic Safety Update Reports (PSUR), post-market clinical follow-up (PMCF) and trend reporting under MDR/IVDR post-market obligations.
Our Process
A clear, predictable process — signing and registration typically start within 1–2 weeks.
Needs Assessment
Confirm product classification, risk class, regulatory route and scope; receive a proposal and quote.
Agreement
Sign the bilingual authorized-representative agreement with the authorized product list and both parties' duties.
Document Review
Review the declaration of conformity, technical documentation and EC-REP labelling compliance.
Registration & Labels
Complete EUDAMED registration, obtain the SRN and update labels before market placement.
Ongoing Maintenance
Vigilance reporting, FSCA coordination, authority communication and annual file updates.
Our Advantages
Established EU Entities
Representation through established local entities in Portugal and Estonia — real places of business, ready for competent-authority inspection at any time.
Bilingual, Zero Time-Zone Friction
Direct communication with our Shenzhen-based team; EU-side partners handle local matters. Correspondence and regulatory files in both languages — responsive and transparent.
A Long-Term Compliance Partner
Authorized representation is a multi-year compliance commitment, not a one-off registration. Documented processes and annual maintenance carry your products through their full lifecycle.
Frequently Asked Questions
When must a European Authorized Representative be appointed?
Whenever a manufacturer has no registered place of business in the EU and wants to place devices on the EU market. The requirement applies to medical devices under the MDR and in-vitro diagnostics under the IVDR alike.
What is the difference between an EC-REP and an importer?
The EC-REP is the manufacturer's legal representative in the EU — involved in registration, document retention and vigilance communication. The importer is the EU-based entity that first places the device on the market, responsible for verifying compliance and indicating its own details. The roles are distinct and cannot substitute for each other.
What liabilities does the EC-REP bear?
Under MDR/IVDR Article 11: verify and keep copies of the declaration of conformity and technical documentation, cooperate with authorities on preventive and corrective actions, respond promptly to requests for conformity evidence, and terminate the mandate if the manufacturer violates its obligations. Under the MDR/IVDR, the representative bears joint liability with the manufacturer for defective devices.
What should I watch out for when changing representatives?
A change involves the handover of responsibilities between old and new agreements, EUDAMED registration updates, label and IFU changes (with a plan for products already on the market), and — advisedly — notifying the relevant authorities. We can manage the full switch for you.
Is a representative still required during the MDD/AIMDD transition period?
Yes. Even if products continue to circulate under legacy-directive certificates during the transition, the obligation for non-EU manufacturers to designate an authorised representative remains — and all MDR/IVDR requirements apply once the transition ends.
How long does the process take?
Needs assessment and quotation typically take 1–2 working days; agreement and document review about one week; EUDAMED registration and label updates usually start within 1–2 weeks, depending on the number of products. Annual maintenance follows.
How are the fees calculated?
Fees typically comprise a contracting assessment fee and an annual maintenance fee, determined by the number of products and risk classes. Submit your product information via the contact page and we will quote within 24 hours.
Ready to appoint your EC-REP?
Submit your product list and CE certification status — receive a proposal and quote within 24 hours.