EU Authorized Representative
Sell your medical devices in Europe — with confidence and compliance.
If you’re a non-EU manufacturer, EU MDR 2017/745 and IVDR 2017/746 require you to appoint a legally established Authorized Representative (AR) in the European Union.
qointa provides full-scope AR services that ensure regulatory compliance, protect your market access, and safeguard your reputation.
What We Offer
As your EU AR, qointa will:
Act as your official point of contact with EU Competent Authorities
Register your device in EUDAMED
Hold and maintain your technical documentation
Monitor compliance with EU MDR / IVDR
Support post-market surveillance and vigilance
Represent your company in case of inspections or incidents
EU Authorized Representative – Pricing Packages
All pricing per product family. All-inclusive. Compliant with EU MDR 2017/745 and IVDR 2017/746.
| Package | Device Class | Annual Fee | Setup Fee | Includes |
|---|---|---|---|---|
| Essential | Class I / General IVD | €5,000 | €2,500 | EU AR, EUDAMED registration, basic documentation review, regulatory contact, annual report support |
| Professional | Class IIa / IIb / IVD Class B/C | €10,000 | €4,000 | All Essential + vigilance support, PMS review, 1h/month consulting, incident handling |
| Premium | Class III / Implantables / IVD Class D | €18,000 | €6,500 | All Professional + full documentation audits, 24/7 support, priority response, 3h/month consulting |
All-In: Premium Full-Compliance EU Entry Package
Your turnkey EU market access solution
| Package | Device Class | Total (Year 1) | Renewal (Year 2+) | Includes |
|---|---|---|---|---|
| All-In | Class IIb / III / IVD Class C/D | €36,000 | €23,000–€26,000 | Premium AR + PRRC service + EUDAMED registration + PMS program setup + Vigilance & incident support + Label/IFU review + Audit readiness + Regulatory strategy consulting |
Notes:
- Pricing is per product family.
- Minor variants (e.g., size, color, packaging) are included.
- Multi-family, multi-year, or portfolio discounts available.
- Services delivered in full compliance with EU MDR/IVDR and ISO 13485:2016.
“qointa’s packages are your complete, one-contract solution to launch and maintain compliant market access in Europe. From Authorized Representation and PRRC to documentation, PMS, and EUDAMED — we do it all, so you don’t have to.”