FAQ - EU, UK and Swiss Authorized Representation

Manufacturers outside the EU need local representation to sell medical devices, IVDs, cosmetics and consumer products in the EU, the UK and Switzerland. This page answers the questions we hear most often, from the Authorized Representative role under MDR and IVDR (written "Authorised Representative" in British English) to EUDAMED, GPSR and the UK Responsible Person.

In brief:

  • Every manufacturer without a place of business in the EU needs an EU Authorized Representative under Article 11 MDR and IVDR, whatever the risk class.
  • Manufacturers without a place of business in Great Britain or Switzerland need a representative there as well. One provider can cover all three markets.
  • Four EUDAMED modules have been mandatory since 28 May 2026.
  • Cosmetics and consumer products follow separate Responsible Person rules.

Your question is not listed? → Contact us.

1. EU Authorized Representative: Role, Tasks and Symbol

Every manufacturer outside the EU needs an EU Authorized Representative to place medical devices or IVDs on the EU market. The answers below explain the role, its tasks and what happens when a manufacturer switches representatives. How MedNet takes on the role is described on our EU REP service page.

2. UK Responsible Person

Great Britain has its own medical device rules and its own representative role. The answers below show how the UK Responsible Person relates to the EU Authorized Representative. Our UK Responsible Person page describes the service in detail.

3. Switzerland / CH-REP

Since the EU-Switzerland MRA lapsed for medical devices in 2021, Switzerland has been a third country and requires its own representative. This section explains who needs a CH-REP and what the updated agreement means in practice. Details on our service are on the Switzerland page.

4. EUDAMED: Mandatory Modules and Who Does What

EUDAMED is now part of the regulatory routine for manufacturers and their Authorized Representatives. The answers below cover the mandatory modules, how Actor Registration works and who is responsible for registering devices. Our Product Registration page describes how we can support with device data.

5. GPSR Responsible Person for Consumer Products

The General Product Safety Regulation applies to consumer products that no more specific EU law covers. The answers below explain which products fall under it and why manufacturers outside the EU need a Responsible Person. Our GPSR page describes how we cover the role.

6. Responsible Person for Cosmetics (EU and UK)

Every cosmetic product on the EU market needs a Responsible Person. The answers below cover the role in the EU and the UK and how it differs from medical device representation. The service itself is described on our Responsible Person page.

7. PRRC, Complaints and Incident Reporting

The PRRC sits inside the manufacturer, the Authorized Representative outside it. The answers below clarify how the two roles differ and what happens when complaints or serious incidents come up. The Authorized Representative's tasks are listed on our EU REP service page.

8. Classification and Market Access under the MDR

Classification determines the conformity assessment route, but the Authorized Representative requirement does not depend on it. The answers below cover the MDR classes, Class I products and the difference between CE marking and designating a representative. Our Medical Devices page gives an overview of the sector.

8a. IVDR: Classes, Transition Deadlines and Representation

The IVDR has its own risk classes, its own transition deadlines and its own rules for performance studies. The answers below cover classification, the deadlines for legacy devices and representation for performance studies. Our In Vitro Diagnostics page summarizes the sector.

9. Working with MedNet EC-REP

These answers cover the practical side of working with MedNet EC-REP, from the first documents to regional coverage. If your question is not listed, contact us.

Ready to appoint a representative?

If you manufacture outside the EU, the UK or Switzerland and need a representative for one or more of these markets, MedNet EC-REP can take on the role. Tell us which markets and product types you have in mind, and we will get back to you with the next steps. We act as your representative and do not provide regulatory consulting. Need an EU REP? → Contact us.



Sources

•      Regulation (EU) 2017/745 (MDR), EUR-Lex
•      Regulation (EU) 2017/746 (IVDR), EUR-Lex
•      Regulation (EU) 2024/1860 amending the MDR and IVDR (EUDAMED roll-out, IVDR transitional provisions), EUR-Lex
•      Commission Implementing Decision (EU) 2025/2371 on the functionality of EUDAMED modules, EUR-Lex
•      MDCG 2022-16, Guidance on authorised representatives under Regulation (EU) 2017/745 and Regulation (EU) 2017/746, European Commission
•      Regulation (EU) 2023/988 (General Product Safety Regulation), EUR-Lex
•      Regulation (EC) No 1223/2009 (Cosmetic Products Regulation), EUR-Lex
•      Swissmedic, Mandatory registration of devices in swissdamed
•      HPRA, IVDR transitional provisions
•      MedDeviceGuide, EU-Switzerland MRA update 2026
•      MedNet EC-REP: EUDAMED's first modules become mandatory
•      MedNet EC-REP: EC REP to EU REP symbol change (EN ISO 15223-1)


Reviewed by the MedNet EC-REP Regulatory Affairs Team · Last updated: 14.10.2026

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