Best EU Authorized Rep (EC REP) | Compare & Get Quotes

Under EU MDR 2017/745^[1] and EU IVDR 2017/746^[2], non-EU manufacturers placing medical devices or IVD on the EU market must appoint an EU authorized representative (also known as EC REP, European authorized representative, or CE authorized representative)^[1][2].

This requirement applies to:

• Non-EU medical device manufacturers placing devices on the EU market^[1] — an EU authorized representative is mandatory for market access
• Non-EU IVD manufacturers placing IVD on the EU market^[2] — requires an authorized representative EU under IVDR
• Manufacturers transitioning from MDD/AIMDD to MDR or IVDD to IVDR — must appoint an MDR authorized representative or authorized representative MDR
• New market entrants from outside the EU — need a European authorized representative before placing devices on the market

Note: The EU authorized representative (EC REP) must be established in an EU member state^[1] and cannot be the same entity as your importer or distributor for the same device^[1].

EU authorized representative services (also called European authorized representative services or EU authorised representative services) typically include:

• Regulatory representation: Acting as your legal representative in the EU for regulatory purposes^[1] — the CE authorized representative fulfills this core requirement
• Technical documentation access: Maintaining access to your technical documentation for authorities^[1] — required for authorized representative medical devices
• Authority communication: Serving as contact point with EU competent authorities^[1] — the EU representative medical device handles all regulatory communications
• Vigilance support: Handling incident reporting and field safety corrective actions^[1] — essential for MDR authorized representative compliance
• Post-market surveillance: Supporting PMS activities and periodic safety update reports (PSURs)^[1] — part of authorized representative MDR obligations
• Change notifications: Managing notifications for device changes to authorities
• EUDAMED support: Some providers assist with EUDAMED registration and updates

EC REP pricing varies based on:

• Device classification: Class III^[1] and IVD Class D^[2] devices typically cost more than Class I
• Portfolio size: Number of devices and device families
• Service scope: Basic representation vs. full regulatory support
• Surveillance needs: Post-market surveillance and PSUR requirements^[1]
• Change frequency: How often you make device changes requiring notifications
• Contract terms: Annual retainer vs. per-device fees

Key factors to consider when selecting an EU authorized representative:

• EU establishment: Verify they're established in an EU member state^[1] — required for EU authorized representative services
• Device class experience: Confirm experience with your device classifications, especially Class III^[1] and IVD Class D^[2]
• MDR/IVDR expertise: Verify they support both MDR^[1] and IVDR^[2] if needed — European authorized representative providers should cover both
• Vigilance capabilities: Assess their incident reporting and FSCA handling^[1] — essential for MDR authorized representative compliance
• Response times: Verify SLA for authority requests and change notifications — EU authorized representative responsiveness is critical
• Additional services: Check if they offer PRRC, EUDAMED, or other complementary services
• Conflict of interest: Ensure they're not also your importer/distributor^[1] — CE authorized representative must be independent

To onboard with an EU authorized representative efficiently, providers typically ask for:

• Manufacturer details: legal entity info, manufacturing sites, authorized signatories
• Device portfolio list: device families, classification^[1], intended use, and markets
• Certificates: ISO 13485^[2], notified body certificates (if applicable)^[1], DoC summaries
• Labeling/IFU: samples showing the EU AR details placement requirements^[1]
• UDI/EUDAMED context: UDI strategy, SRN needs, and current EUDAMED status
• Vigilance/PMS contacts: who will respond to authority requests and incident timelines^[1]

Tip: If you have multiple device classes, ask VAT fiscal representative services providers whether pricing is per device, per family, or per portfolio band.

EU authorized representative timelines vary by device class and portfolio complexity. Typical milestones:

• Provider selection: 1–2 weeks (quotes + contract review)
• Onboarding + appointment: 1–4 weeks (depending on document readiness)
• Label updates: 2–6 weeks (design + approvals + printing lead times)^[1]
• EUDAMED alignment: variable (depends on modules used and readiness)

If your timeline is urgent, prioritize European authorized representative providers with clear onboarding SLAs and a defined escalation process.

EU AR contracts are not interchangeable. Compare providers on:

• Scope: MDR, IVDR, or both; portfolio coverage and change notification terms
• Authority handling: response SLAs, weekend/holiday coverage, escalation contacts
• Documentation access: how technical documentation is stored/accessed for authorities
• Liability + insurance: caps, exclusions, and professional indemnity coverage
• Termination + transition: notice periods and obligations to support a handover