EU Authorized Representative for Medical Device & IVD Companies
Last reviewed:
Medical device manufacturers located outside the European Union must appoint an EU Authorized Representative (AR) to sell their devices on the EU market.
What is an EU Authorized Representative?
Under the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746, medical device manufacturers located outside the European Union must appoint an EU Authorized Representative (AR) to sell their devices on the EU market. This is not a new requirement, though the regulations expanded compliance requirements for ARs and increased their legal liability. The AR acts as a legal representative for manufacturers, serving as a point of contact for EU Competent Authorities and Notified Bodies (NBs), and is responsible for ensuring the device’s compliance with regulatory requirements. This role is symbolized through an EU Representative logo (EU REP) as a mandatory symbol. They must also register in EUDAMED.
The Role of your Authorized Representative
Your AR performs essential responsibilities in the pre- and post-market stages of CE Marking. ARs are legally liable on the same basis as manufacturers for defective medical devices if the manufacturer has not complied with regulatory requirements. As such, ARs are responsible for ensuring your Technical Documentation meets the requirements of MDR/IVDR and is up to date (in conformity to applicable regulations). They will also act as the contact point for EU authorities and keep a copy of your Technical Documentation on file to supply to NBs or Competent Authorities on request. The AR’s details also appear on your device’s labeling and packaging.
After your device is CE Marked and placed on the market, your AR assists with ongoing compliance, helping to address any complaints or incidents, and liaises with regulators to support field safety corrective actions (FSCAs) and recalls.
How to choose an EU Authorized Representative for MDR and IVDR compliance
Choosing the right AR is crucial to successful market entry in the EU, as well as minimizing legal and regulatory risks for your company. The AR is the legal entity, and you must sign a written mandate that outlines the AR’s obligations. At the very least, your AR must be an individual or company with a physical address in an EU Member State. Make sure your AR fulfills the criteria in Articles 11, 12 and 15 of the MDR and IVDR. MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - October 2022 is another useful tool to understand the scope of the AR role. If your AR does not maintain compliance with their regulatory obligations, it can compromise your compliance as well.
In addition to these minimum requirements, your AR should have in-depth knowledge of the MDR/IVDR and experience handling regulatory submissions, particularly in your device category. They should also have the resources and personnel to respond quickly to compliance issues and EU authority communications. For these reasons the AR, similar to the manufacturer, has to appoint a Person Responsible for Regulatory Compliance (PRRC), which must be permanently and continuously at their disposal.
Regulatory authority and source of truth
This service sits within the current requirements administered by the relevant regulator. Use that glossary entry for the authority's remit, official portal, and contact points; use this page for the task-specific workflow and deliverables.
Case Study · Aug 11, 2026Basic UDI-DI Grouping for Contrast DevicesCase Study · Aug 11, 2026Class III Dermal Fillers Under the EU MDRCase Study · Aug 5, 2026EU Authorized Representative for Surgical RobotsRegulatory Update · Jul 29, 2026EU Notified Body Standard-Fee List UpdatedRegulatory Update · Jul 29, 2026MDCG 2026-5 on UDI AssignmentRegulatory Update · Jun 25, 2026EU Harmonized Standards 2026 UpdateRegulatory Update · Jun 25, 2026MDCG 2021-5 Rev.1 EU REP Symbol TransitionBlog · Aug 10, 2026Surgical Robots: Eight Markets, Eight Regulatory FilesBlog · Aug 3, 2026ISO 10993-1:2025: One Core, Seven Regulatory SystemsBlog · Jul 27, 2026IVD Global Market Access 2026EU Representation for a Simple Annual Fee
We act as your EU Authorized Representative for a flat annual fee from $2,000/year — EUDAMED support, document review, and CFS processing included.
Frequently asked questions
The MDR and IVDR require all manufacturers selling in the EU to appoint a Person Responsible for Regulatory Compliance (PRRC), who is responsible for ensuring the manufacturer’s quality management system (QMS), regulatory documentation, post-market surveillance and vigilance reporting process, etc., meet EU MDR or IVDR requirements. If the manufacturer is not in the EU, they must appoint an EU Authorized Representative. The AR will also have to have a PRRC to meet legal obligations and supporting the manufacturer’s PRRC in post-market surveillance and vigilance issues and communication with the competent authority.
Before signing the mandate, the AR is obliged to verify that the manufacturer is in conformity with the applicable EU regulations. This control typically is done through a review for key documents of the manufacturer’s Technical Documentation (e.g., QMS, Declaration of Conformity, GSPR, Risk Management, labeling, performance data, post market surveillance, vigilance). The AR must also keep copies of the current Technical Documentation and make them accessible to competent authorities on request. They must verify that the manufacturer has registered the represented devices and manufacturer information in EUDAMED or the database of the EU member state, where the EU AR has its registered place (MDR/IVDR Article 11(3)(c)).
Your EU AR cannot represent your device in markets outside the EU unless your AR has a physical presence and personnel in those markets. Even then, your relationship must adhere to the regulatory requirements for in-country representation in those markets. This includes the UK and Switzerland since they are not EU Member States. However, there are similar obligations for qualified personnel defined by national laws in UK and Switzerland to meet the regulatory controls necessary for representatives. These personnel must be appointed separately.
Authorized Representatives are accountable to and supervised by competent authorities in the member state where the AR is based. They may be audited on a regular basis or by cause.
Single Process,
Multiple Markets
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us