EU Authorised Representative for Medical Devices
Placing medical devices on the EU market from outside the European Union? Conregia supports non-EU manufacturers with EU-Rep services, MDR documentation review, EUDAMED/SRN coordination and practical market-access guidance.
Conregia is a Germany-based regulatory compliance partner for international manufacturers that need a professional EU contact under the Medical Device Regulation without building a full in-house EU regulatory department.
Do you need an EU Authorised Representative?
Start here if you manufacture medical devices outside the EU and plan to sell through importers, distributors, marketplaces or direct B2B channels in Europe.
Are you outside the EU?
Manufacturers without an EU establishment must designate an authorised representative for devices placed on the EU market.
Is your product a medical device?
The intended purpose, claims, technical function and classification determine the MDR route and documentation expectations.
Is your documentation ready?
Before appointment, Conregia reviews the device scope, MDR documentation and EUDAMED-related data requirements.
MDR Article 11 support with a structured mandate
Conregia supports eligible non-EU manufacturers with a mandate-based EU Authorised Representative setup. The service is designed for companies that need a reliable regulatory contact, practical documentation review and clear communication with EU market actors.
- Review of manufacturer role, device scope and MDR route
- Preparation and acceptance of a written EU-Rep mandate
- Verification that required declarations and technical documentation are available
- Competent-authority communication according to the mandate
- Forwarding of complaints, reports and vigilance-related information
- Coordination with importers, distributors and notified bodies where relevant
The authorised representative role does not transfer the manufacturer’s MDR obligations. The manufacturer remains responsible for device conformity, technical documentation, clinical evaluation, PMS, vigilance, QMS readiness and conformity assessment where required.
Prepare actor registration and device data before market launch
EUDAMED is now a practical part of EU market access. As of 28 May 2026, the first four EUDAMED modules became mandatory to use, including Actor registration and UDI/Device registration.
SRN readiness
Conregia helps coordinate manufacturer, EU-Rep and supply-chain actor information for EUDAMED registration consistency.
EU-Rep alignment
The represented device scope, mandate wording and actor information should match before EUDAMED-related submissions are finalised.
UDI and registration checks
We support practical checks for device registration data, labelling references, UDI information and documentation consistency.
What we review before appointment
A strong EU-Rep relationship starts with transparent documentation. Conregia reviews whether the device file is ready for a mandate or whether critical gaps need to be closed first.
Classification and intended purpose
Device type, intended use, claims, classification rationale, applicable MDR rules and notified-body involvement.
Technical and conformity documentation
EU Declaration of Conformity, technical documentation, GSPR checklist, labels, IFU, certificates and manufacturer details.
Clinical, PMS and vigilance readiness
Clinical evaluation, risk management, post-market surveillance, complaint handling and incident reporting processes.
Documentation-first onboarding
This approach protects both the manufacturer and the EU-Rep by clarifying the regulatory baseline before the mandate is accepted.
Your route to EU-Rep appointment
Conregia keeps the process structured, commercial and manageable for international medical device manufacturers.
Initial product review
We review the device description, intended purpose, classification, manufacturer details and target EU market route.
Document and EUDAMED check
We assess the available MDR file, mandate scope, EUDAMED actor data and device-registration readiness.
Mandate and ongoing support
After successful review, the mandate is finalised and Conregia acts as the agreed EU regulatory contact.
Built for regulated EU market access
Medical device compliance requires careful documentation, clear responsibilities and reliable communication with authorities and market partners.
A practical EU-Rep partner for international manufacturers
MDR obligations are technical, but your route to market should be understandable. Conregia translates regulatory requirements into a structured action plan for manufacturers that need a professional EU presence and reliable coordination.
- Clear explanation of EU-Rep requirements in business language
- Support for non-EU manufacturers entering Germany and the EU
- Coordination around documentation, EUDAMED and supply-chain expectations
- Long-term regulatory contact for represented devices within the agreed mandate
From uncertainty to an appointment-ready file
Many manufacturers know they need an EU-Rep but do not know whether their documentation is ready. Conregia helps turn that uncertainty into a practical checklist and onboarding route.
- Clarify manufacturer and device scope
- Identify MDR documentation gaps
- Align mandate scope with device data
- Prepare EUDAMED/SRN coordination points
- Set up ongoing communication channels
Exact requirements vary by device type, classification, conformity assessment route and Member State expectations. Conregia reviews each case before confirming the possible mandate scope.
Medical device EU-Rep questions
Who needs an EU Authorised Representative under the MDR?
Manufacturers not established in an EU Member State need an authorised representative before placing medical devices on the Union market. The appointment must be accepted in writing and must cover the relevant device scope.
What does an EU-Rep do under MDR Article 11?
The authorised representative performs the tasks specified in the mandate. This includes keeping certain documents available, supporting authority communication and forwarding relevant requests, complaints and reports to the manufacturer.
Does Conregia replace the manufacturer’s MDR obligations?
No. The manufacturer remains responsible for device conformity, technical documentation, clinical evaluation, PMS, vigilance, QMS and conformity assessment where required. The EU-Rep role is defined by the MDR and the written mandate.
Can Conregia support EUDAMED and SRN preparation?
Yes. Conregia can support actor-data coordination, SRN readiness, mandate consistency checks and practical alignment between EUDAMED information, device scope and supply-chain communication.
Can Conregia act for all medical device types?
Each request must be reviewed first. The possible mandate depends on device type, risk class, documentation maturity, conformity assessment route and whether the manufacturer can maintain the required MDR obligations.
Need an EU Representative for medical devices?
Send us your device description, classification, target EU market and available MDR documentation. Conregia will review the next steps and help you prepare a clear route to appointment.
For direct enquiries, use: “Medical Device EU-Rep MDR Article 11 Request”.