EU Authorized Representative for Medical Devices and IVDs
Non-EU manufacturers must appoint an EU-based Authorized Representative (EC-REP) before placing CE-marked medical devices or in vitro diagnostics on the European market. We handle the full obligation - so you don't have to.
Appoint your EU Authorized Representative
What Is an EU Authorized Representative?
An EU Authorized Representative - also called EC-REP or EU-REP - is a legally required appointment for any manufacturer established outside the European Union who markets CE-marked medical devices or IVDs in the EU.
Your EC-REP acts as your official interface with EU Competent Authorities. Their name and address must appear on your device label, and they must be registered in EUDAMED.
Failing to appoint an EU Authorized Representative means your products cannot legally be placed on the EU market - and can trigger enforcement action by national authorities.
Required under MDR 2017/745 for all non-EU manufacturers of CE-marked medical devices from Class I through Class III, including sterile and measuring devices.
Required under IVDR 2017/746 for all non-EU manufacturers of CE-marked IVDs from Class A through Class D, including companion diagnostics.
Full EU Authorized Representative Service - Included as Standard
Appointing MedNet as your EU Authorized Representative means every regulatory obligation is covered. Here is what we handle on your behalf:
Official contact for EU Competent Authorities
We serve as your registered point of contact for all national and EU-level regulatory authorities - including the German BfArM, the French ANSM, and all other national competent authorities in the EU/EEA.
Vigilance reporting and safety notifications
We handle all serious incident reporting and field safety corrective actions (FSCAs) as required under MDR and IVDR, coordinating with you and the relevant authorities throughout the process.
Retention of technical documentation
We keep your Declaration of Conformity and a copy of your technical documentation on file and make it available to EU Competent Authorities upon request.
Regulatory correspondence and updates
We handle all incoming and outgoing regulatory correspondence and keep you proactively informed of any changes to MDR, IVDR, or EUDAMED requirements that may affect your products.
MDR and IVDR - Both Covered
Whether you manufacture medical devices or in vitro diagnostics, MedNet provides fully compliant EU Authorized Representative services under both EU regulations.
Medical Devices
For manufacturers of CE-marked medical devices who require an EU Authorized Representative under the Medical Device Regulation.
- Class I, IIa, IIb, and III devices
- Sterile and measuring Class I devices
- Custom-made devices (where applicable)
- Post-market surveillance support
In Vitro Diagnostics
For manufacturers of CE-marked in vitro diagnostic devices who require an EU Authorized Representative under the In Vitro Diagnostic Regulation.
- Class A, B, C, and D IVDs
- Self-test and near-patient testing devices
- IVDR vigilance reporting
Your EU Authorized Representative - Not Just a Name on a Label
Many EC-REP providers offer a name and address. MedNet offers a team. Here is what makes us different.
PhD-level regulatory expertise
Our regulatory affairs team consists of biologists and medical engineers - with roughly half holding a PhD. Your EC-REP obligation is managed by people who understand the science and the regulation.
One dedicated contact - not a ticket system
You get a named contact from our RA team who knows your products and your regulatory situation. Questions are answered by people, not queues.
Transparent pricing - no hidden fees
No onboarding fees. No document verification fees. The annual fee quoted is the annual fee you pay. We think that's how it should work.
Fast setup - draft contract in 24 hours
Send us your product details and we'll have a draft contract ready for your review within one business day. No waiting weeks to get started.
Frequently Asked Questions
Ready to Get Started?
Appoint Your EU Authorized Representative Today
Send us your product details and we'll have a draft EC-REP contract ready for your review within 24 hours. No commitment required.
MedNet EC-REP GmbH
Borkstrasse 10, 48163 MÃŒnster, Germany