EU Authorised Representative Cost

Yes, they are separate costs. The EU Rep fee pays for legal representation in the EU. Notified Body fees pay for conformity assessment and CE certification of Class Is/Im/Ir, IIa, IIb and III devices, and they are usually much higher. Class I self-certified devices need an EU Rep but no Notified Body.

Common hidden cost involved in EU Representative for medical and IVD are the following:

• Mandate or agreement modification post signing for any significant reason (€150)
• No Objection Certificate for switching providers (€100)
• EUDAMED data removal (€50)
• UDI registration (€300 per registration)
• custom-made device surcharges (+€200/year)

Not always. A very low EU Rep fee may exclude EUDAMED registration, vigilance support or regulatory review. When comparing EU Authorized Representative fees, check:

• what services are included
• the provider’s regulatory experience
• whether pricing is transparent
• the response time to Competent Authority requests

With I3CGLOBAL, signing the EU Rep agreement takes 4–5 working days, and EUDAMED and EU registration take 10–16 working days. Fees are payable in advance, and a signed Declaration of Conformity with EMDN/GMDN codes is needed to start.

Yes, you can switch EU Representatives at any time. The process needs a new mandate, updated labelling, EUDAMED actor data updates and, usually, a No Objection Certificate from the current EAR. At I3CGLOBAL, issuing an NOC costs €100 and modifying a mandate costs €150.

Yes. EU Rep services based in Germany usually cost more than those in other EU member states such as Portugal. Both locations carry identical legal responsibilities under EU MDR and IVDR. I3CGLOBAL offers both, and the Portugal office is the best-value option.

Yes. The annual EU Representative service fee includes one device, and each additional device is charged per year. If your devices fall into different classes, the fee is based on the highest risk class. Devices with different intended uses or designs cannot be merged under one Declaration of Conformity.

For IVDs under the IVDR, the EU Rep fee depends on the IVD class (A, B, C or D) and the number of devices. Use the I3CGLOBAL fee calculator on this page and select “In-Vitro Diagnostic Device” to see your exact annual fee and first-year total.

The EAR service fee typically covers:

• acting as your legal contact with EU Competent Authorities and Notified Bodies
• verifying your Declaration of Conformity and technical documentation
• keeping documentation available for inspection
• supporting vigilance and field safety actions
• managing your EUDAMED actor registration
• placing the EU Rep name and address on your labelling

Higher-risk devices (Class IIb and III) need more oversight from the EU Representative. That includes verifying technical documentation, Notified Body certificates, vigilance reporting and field safety corrective actions. More responsibility and liability means a higher annual European Authorized Representative fee.

Yes. The EU Rep fee is an annual recurring fee, paid in advance. The EAR stays legally responsible for your devices on the EU market for as long as the mandate is active, so the service continues every year. One-time costs such as EUDAMED setup and Competent Authority fees apply only in the first year.

The first-year cost includes three parts: the annual EU Rep fee, a one-time EUDAMED user access setup (€300, optional) and a mandatory one-time Member State Competent Authority fee (€400). For a Class I device, the first year totals €1,600. From the second year you pay only the annual fee (€900).

I3CGLOBAL’s annual EU Rep fees (Portugal office) are:

• Class I: €900
• Class Is/Im/Ir: €1,000
• Class IIa: €1,100
• Class IIb: €1,250
• Class III: €1,500

Each fee covers one device. Additional devices are charged per device per year.

For non-EU medical device manufacturers, an EU Authorised Representative (EU Rep) usually costs a few hundred to several thousand euros per year. The price depends on device class, number of devices and the provider. At I3CGLOBAL, the annual EU Rep fee starts at €900 per year for Class I devices and goes up to €1,500 per year for Class III devices (Portugal office).