EU Authorized Representative Services for Medical Devices (MDR & IVDR)
Mandatory for any non-EU manufacturer selling medical devices or IVDs in the EU under MDR 2017/745 and IVDR 2017/746.
EU REPRESENTATIVE APPOINTMENT
4 Working Days
EUDAMED REGISTRATION
10 Working Days
FREE SALE CERTIFICATE (FSC)
30 Working Days
Quick Contact
What is an EU authorized representative?
An EU authorized representative (also called EC REP or EU REP) is a legal requirement for any non-EU manufacturer wishing to sell medical devices or in-vitro diagnostic devices in the European Union. Under MDR 2017/745 and IVDR 2017/746, foreign manufacturers must appoint a single European authorized representative before placing any product on the EU market. I3CGlobal provides dedicated EU authorized representative services for medical device manufacturers across Asia, North America, and beyond, with EUDAMED registration completed in as little as 10 working days.
Why non-EU manufacturers need an EU Representative
If you manufacture medical devices outside the EU and want to sell in Europe, you need an EU authorized representative (also referred to as EU REP or EC REP), one legal entity, based inside the EU, formally appointed before a single device crosses the border.
Article 11(1) of MDR 2017/745 requires non-EU manufacturers to designate a sole EU authorized representative as a condition of market access. IVDR 2017/746 Article 11(1) mirrors this requirement word for word for in-vitro diagnostic devices. For IVD manufacturers, the IVDR authorized representative carries the same legal standing and the same liability exposure under Article 11(5) of IVDR 2017/746.
The role goes well beyond a contact name. The EU authorized representative (AR) must keep your technical documentation and Declaration of Conformity on hand (Annex II and Annex IV, MDR/IVDR), register devices in EUDAMED, and cooperate with national authorities on recalls and corrective actions. Under Article 11(5) of both regulations, if the manufacturer does not meet its obligations, the AR can be held jointly and severally liable for defective devices. That is a meaningful legal exposure, not a rubber stamp.
The conformity assessment records the AR must retain are governed by Annex IX (MDR and IVDR). EU authorities need someone within their jurisdiction they can audit, contact, and hold responsible. That is the whole point of the requirement.
Roles and Obligations of an MDR Authorized Representative
Any manufacturer outside the EU must appoint a single European authorized representative before a medical device reaches the European market, a hard requirement under Article 11 of MDR 2017/745, regardless of device class.
The MDR authorized representative holds your Technical Documentation, EU Declaration of Conformity, and CE certificates for the period under Article 10(8), verifies UDI and registration obligations under Articles 27, 29, and 31, and supplies conformity documentation to competent authorities in the required Member State language on request.
Operationally, they handle vigilance reporting, support field safety corrective actions, and relay adverse events from healthcare professionals or patients back to the manufacturer. They are who EU authorities call when something goes wrong, not an admin layer.
Under Article 11(5), if the manufacturer fails its Article 10 obligations, the EU authorized representative faces joint and several liability for defective devices. The mandate can be terminated if the manufacturer stops complying and the competent authority must be notified when that happens.
Roles and Obligations of an IVDR Authorized Representative
Article 11 of IVDR 2017/746 sets the same base requirement for IVD manufacturers: one IVDR authorized representative in the EU, appointed in writing, before any in-vitro diagnostic device enters the European market.
The representative maintains Technical Documentation, Declaration of Conformity, and certificates under Article 10(7), verifies EUDAMED registration and UDI compliance under Articles 24, 26, and 28, and produces conformity documentation for authorities on request. Physical access to device samples is facilitated through them too.
Post-market is where IVD representatives earn their keep. Incident reports and safety communications from laboratories, clinicians, or patients go through the representative to the manufacturer as they are the first contact point during inspections and market surveillance.
Under Article 11(5) of IVDR 2017/746, the IVDR authorized representative can be held jointly and severally liable for defective IVD devices where the manufacturer has failed its obligations. Authorities must be notified when the mandate is withdrawn.
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Our European Authorized Representative Services
I3CGlobal serves as European authorized representative for medical device and IVD manufacturers entering the EU market under MDR 2017/745 and IVDR 2017/746. Here is exactly what that covers.
- Liaison with European National Competent Authorities and Notified Bodies
- We review your EU Declaration of Conformity and Technical Documentation against MDR or IVDR requirements. Any compliance issues will be informed
- Your latest revisions of technical documentation files stored in safe custody and produced to EU authorities when requested.
- We register your organisation and products in EUDAMED and obtain your Single Registration Number (SRN)
- A qualified Person Responsible for Regulatory Compliance (PRRC) inside the EU, covering all regulatory duties
- Our name, address, and EC REP symbol on your packaging, labels, and IFU
- Complaints from users go to your team. Serious adverse incidents, FSCAs, and recalls go to EU authorities from us, immediately.
- We carry equal legal and financial liability for defective devices on the EU market alongside you.
EU Representative Agreement and Mandate Documents
The terms “EU Representative Agreement” and “Mandate” are often used interchangeably but can have slightly different contexts. However, in the context of appointing an EU authorized representative or European authorized representative for medical devices, they typically refer to the same contractual arrangement between the foreign manufacturer and the EU Representative.
EU Representative Agreement: This is a formal agreement or contract between the manufacturer and the European authorized representative. It outlines the responsibilities, duties, and obligations of both parties regarding regulatory compliance, communication with authorities, and other relevant aspects related to the marketing of medical devices within the European Union under MDR 2017/745 and IVDR 2017/746.
Mandate: This refers to the authorisation granted by the manufacturer to the European authorized representative to act on its behalf within the EU market. This mandate empowers the EU authorized representative to fulfil certain tasks and responsibilities outlined in the agreement. It essentially delegates certain regulatory and compliance-related functions to the representative.
In summary, while the terms may differ slightly, they generally refer to the same contractual arrangement between the manufacturer and the EC Rep, outlining their respective roles and responsibilities in ensuring compliance with MDR 2017/745 and IVDR 2017/746 for medical devices placed on the EU market.
Appoint I3CGlobal as your EU Authorized Representative for MDR and IVDR. EU Rep / EC Rep contracts in 4 working days. Get a free proposal.
How to Change Your EU Authorized Representative
As per Article 12 of the EU MDR and the EU IVDR, the detailed arrangements for a change of E.A.R should be clearly defined in an agreement between the manufacturer, where practicable, the outgoing EU Representative, and the incoming EC Rep. The agreement should address at least the following aspects:
- Provide a registered address in the EU to be mentioned on the product packaging
- Keep the updated technical documentation available for inspection by the competent authorities
- Represent the manufacturer in front of the European Commission, NB’s and the users
- Device registration and EU Free Sale Certificate
- Take care of incidents reported by the healthcare professionals, patients, and users
- Safeguard the compliance with regulatory news and updates
- Check the registration of the importer, manufacturer with the EU and update accordingly
- EU Representative consult and continuously support the manufacturer
- Terminate the mandate if the manufacturer acts contrary to MDR/IVDR obligations
- Review and guide on PMS, PMCF and PSUR requirements, if required
Benefits of Appointing European Authorized Representative
Our European Authorized Representative services offer complete support for medical device and In-vitro diagnostic manufacturers seeking to enter or maintain their presence in the European market. Below are a few reasons why you might consider our services.
- We are an ISO 27001:2013 Certified data security system. So, all customer inputs and technical documents are safeguarded for many years.
- When judgments must be made that go against the interests of an importer/distributor, we operate in your best interests.
- While distributors and corporate branch offices may have other priorities, we react to inquiries from authorities quickly and effectively.
- Unlike other legal firms and trading organizations, we are regulatory consultants for medical devices. We provide scientific, and regulatory compliance information to all our clients outside the EU ensuring that manufacturers receive accurate information and value for their investment.
Overall, by appointing our EU Representative Services, we guide appropriately and overcome all the complexities of regulations (SRN, ACTOR, UDI, EUDAMED) more efficiently and ensure full adherence with MDR 2017/745 and IVDR 2017/746 requirements for any risk class and type of device.
I3CGlobal is a team of EU regulatory experts serving as European authorized representative for medical device and IVD manufacturers under MDR 2017/745 and IVDR 2017/746. Complete the form below to receive a transparent fee proposal — no obligation.
EU Authorized Representative
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Frequently Asked Questions - EU Authorized Representative
Is the EU Representative fee annual?
Yes. The EU Representative fee is charged annually (12 months from the date of appointment).
What is Product Liability Insurance?
Under Article 10(16) of EU MDR 2017/745 and Article 10(15) of EU IVDR 2017/746, manufacturers are required to establish measures providing sufficient financial coverage in respect of their potential liability for defective medical devices or in vitro diagnostic devices placed on the European market. Product liability insurance is a financial protection mechanism maintained by the manufacturer to cover potential claims, damages, adverse events, or injuries associated with defective devices marketed within the European Union in accordance with applicable European product liability legislation, including Directive 85/374/EEC.
Manufacturers established outside the European Union are generally expected to maintain valid product liability insurance throughout the duration of device commercialization and the validity of the European Authorized Representative mandate. Depending on the contractual arrangement, the insurance policy may also include coverage relating to the activities of the European Authorized Representative due to the potential joint and several liability provisions specified under Article 11 of EU MDR 2017/745 and EU IVDR 2017/746. However, such insurance does not normally protect the Authorized Representative against liabilities arising from unauthorized activities, negligence, breach of contract, or non-compliance resulting directly from the Representative’s own actions or omissions.
Does the European Authorized Representative information need to be on the device label?
Under the MDR and IVDR, the European Authorized Representative name and address must be on the device label; though not mandatory on the IFU. The technical documentation must contain a specimen of the label and IFU/User manual with EAR name and contact information to demonstrate traceability.
To minimize translations, place the EAR information near the EC REP symbol per EN ISO 15223-1:2016. If the label is small, use packaging or IFU. For ‘legacy’ devices under old Directives (MDD, AIMDD, IVDD), EAR info can be on the label, outer packaging, or IFU. The European Authorized Representative information must be detailed in the Declaration of Conformity also.
What about the United Kingdom and Switzerland?
Following the United Kingdom’s withdrawal from the European Union, EU manufacturers must appoint a UK Responsible Person for marketing in the UK. Similarly, due to the lapse of the Mutual Recognition Agreement between Switzerland and the EU for medical devices and IVDs, the EU or UK manufacturers must appoint a Swiss Authorized Representative (CH REP) for marketing in Switzerland.
``EU Representative`` Terms
MDR 2017/745 and IVDR 2017/746 write it as “authorised representative” — British spelling, consistent across all official EU regulation text. EN ISO 15223-1 switches to “authorized representative” — American spelling — and introduces the EC REP symbol you see on device labels and IFUs.
The result is a terminology mess that confuses manufacturers more than it should. EU authorized representative, European authorized representative, EC REP, EAR, EU REP, ECREP, six terms, one role.
Role of European Authorized Representative in case of Serious adverse events during clinical investigation
According to Art. 80 of (EU) MDR 2017/745 and Art. 76 of (EU) IVDR 2017/746, all serious adverse events must be fully recorded and immediately notified to all Competent Authorities of the Member States in which the clinical investigation is being performed by the sponsor. The European Authorized Representative should inform the manufacturer of the decisions of a Member State in respect of the refusal or restriction of the placing of the devices specified in Appendix A in the market.
What is the validity of European Authorized Representative agreement?
Unless terminated earlier as per the agreement terms, generally, the EU-authorized representative contract shall be valid for five (5) years. The Contract will automatically renew for an additional year unless either party cancels it with written notice at least ninety (90) days before the expiration date.
Page updated on 20th May 2026 by Nikhil Prasad and Approved by Joe Kumar