Maven
European Authorized Representative (EAR)

European Authorized Representative for Medical Devices

What is a European Authorized Representative (EAR)?

Want to Sell Medical Devices in Europe? Here’s What You Need to Know!

If your company is based outside the European Union, you must appoint a European Authorized Representative (EAR) to legally place your medical devices on the EU market. The EAR acts on behalf of the manufacturer, ensuring compliance with regulatory requirements and maintaining communication with competent authorities. This partnership is essential as long as you continue selling in Europe.

Choosing the right EU Authorised Representative is crucial to ensuring smooth market access and regulatory compliance. The European Authorized Representative for medical devices plays a key role in handling technical documentation, product registration, post-market surveillance, and regulatory updates.

Not sure whom to appoint or what their exact responsibilities are? Don’t worry—Maven is here to support you! Our team ensures full compliance, easing your workload and helping you meet EU MDR and IVDR obligations effortlessly.

Key Responsibilities of a European Authorised Representative:

  • Ensuring compliance with EU regulations and directives.
  • Keeping and updating the Technical Documentation.
  • Acting as the contact point for EU authorities.
  • Supporting post-market surveillance and vigilance reporting.
  • Ensuring product labeling and Declaration of Conformity requirements are met.

With Maven as your European Authorised Representative, you gain expert regulatory support, allowing you to focus on innovation and business growth while we handle compliance.

European-Authorized-Representative
European Representative

How European Authorized Representative shall perform the following task:

  • Will keep one copy of technical documentation in case Competent Authorities request it for inspection as part of European Authorized Representative services.
  • Will verify that the manufacturer has obeyed with the registration rules that are present in Regulation (EU) 2017/745 and 2017/746, ensuring compliance as an EU Representative for medical devices.
  • In response to a request from a competent authority, provide that authority with all the necessary information and documentation to demonstrate the conformity of a medical device, in an official Union language determined by the Member State concerned, as required for an Authorised Representative in the EU.
  • Informs the manufacturer about suspected incidents obtained from healthcare professionals, patients, and users related to the medical device.
  • The EU Representative for medical devices can terminate the agreement if the manufacturer acts against the rules laid under Regulation (EU) 2017/745 and 2017/746.
  • The European Authorized Representative services provider shall have at least one Person Responsible for Regulatory Compliance (PRRC) who meets the minimum qualification and experience requirements outlined in Regulation (EU) 2017/745.

Change of European representative

The details for a change of European Authorised Representative should be clearly mentioned in the EAR agreement between the manufacturer, outgoing European Authorized Representative Medical Devices, and the incoming representative. This agreement should include the following aspects:

  • The date of termination of the agreement with the outgoing EU Representative Medical Device and the start date of the incoming representative’s agreement.
  • The validity period for the outgoing representative’s details on any promotional materials used by the manufacturer.
  • The transfer of documents, ensuring confidentiality and property rights.
  • The responsibilities of the outgoing representative after the agreement ends, including forwarding necessary information to the manufacturer or incoming representative.
  • Handling of complaints or reports from healthcare professionals, patients, or users regarding suspected incidents related to a medical device.

To designate an European Authorised Representative, an agreement must be signed between the manufacturer and the representative, aligning with the obligations outlined in Regulation (EU) 2017/745 Article 11 or Regulation (EU) 2017/746 Article 11, depending on the applicable medical device.

Change-of-European-representative

Brexit Effects on European Authorized Representative

Want to keep selling your products in the UK & Europe? Brexit has significantly impacted the process of appointing an EU Authorised Representative.

If you are a Non-EU Manufacturer, you must now have two authorised representatives—one in Europe (EU Authorised Representative) and one in the UK (UK Authorised Representative) to continue selling in both markets.

For manufacturers based in the UK looking to sell in Europe, appointing a European Authorised Representative is now mandatory.

Additionally, if you are a Non-EU Manufacturer who previously appointed a UK-based representative before Brexit, you must now switch to an EU Authorised Representative to maintain access to the European market.

Swiss Authorised Representative

If a manufacturer is not located in Switzerland, and wants to place its product on market, you will have to appoint Swiss Authorised Representative. The name and address of the swiss authorized representative shall appear on the label and package of the device. this also applies to manufacturers who have their registered place in the European Union.

European Free Sales Certificate

Got the CE certificate and want to explore global market for your medical device sale? Well, you might end up with the demand of Free Sales Certificate to continue the process.

Once requested by your European Authorized Representative, European Competent Authorities issue this certificate for your medical device so that you can freely sale your medical devices or distribute the devices in that country.

It is not required for the EU based countries. It is only applicable to Non-EU based countries only.

Free-Sales-Certificate

Basic Requirements to obtain a Free Sales Certificate –

  • Compliance with the applicable EU Requirements (Evidences – CE Certificate, Technical File, EU Declaration of Conformity etc.)
  • Appointed EU REP details (Evidences – EU REP Agreement)
  • Registration Details of your organization
  • Quality Certificates (Evidences – ISO 13485/ISO 9001)

Institutions available for legalization of the Free Sales Certificate –

  • The Chamber of Commerce
  • The Ministry of Foreign Affairs
  • The Relevant Embassy

This Free Sales Certificate also has to set out the Basic UDI – DI of the device as per the UDI requirements mentioned in the EU MDR Regulation 2017/745.

Free-Sales-Certificate

WE DO MORE THEN EVER
PLATFORMS

There are many variatns of passages the majority have suffered alteration in some foor randomised words believable.

THEN-EVER-PLATFORMS

The Authorized Representative name, address and symbol will be present on the following-

  • Label
  • Declaration of Conformity
  • Instructions for Use

Yes, a written mandate (agreement) between the organization and the Authorized Representative is a mandatory document which will also have to be submitted in the Technical Documentation of the medical device. All the necessary obligations of the manufacturer and the Authorized Representative have to be included in this contract.

Watch Our Video for a Quick Overview

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