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European Authorized Representative

European Authorized Representative (EAR)

Want to sale the medical devices in Europe?

But wait, your company is situated outside the European Union right?

Yes, you will have to appoint one authorized representative for your company, who will act on manufacturer’s behalf with respect to specified tasks and will have to keep this liaison as long as you want to sell your products in Europe.

Confused about whom to choose as your European Authorized Representative and not sure about their obligations? Don’t hassle! Your support system, Maven, is all prepped up to ease your work and take care of this requirement for you!

First of all, let’s understand the indispensable requirements for which you are going to appoint a European Authorized 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
  • Will verify that the manufacturer has obeyed with the registration rules that are present Regulation (EU) 2017/745 and 2017/746.
  • In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a medical device, in an official Union language determined by the Member State concerned
  • Informs the manufacturer about the suspected incidents obtained from healthcare professionals, patients and users related to the medical device
  • EAR can stop the agreement if the manufacturer acts against the rules laid under Regulation (EU) 2017/745, Regulation (EU) 2017/746
  • The EAR shall have at least one person responsible for regulatory compliance (PRRC) who has minimum qualification and experience as mentioned in the Regulation (EU) 2017/745

Change of European representative

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

  • The date of termination of the agreement of the outgoing European representative and date of beginning of the agreement of the incoming European representative
  • Mentioning the date that can be valid for the outgoing European representative which is used the manufacturer on any promotional material
  • The transfer of documents, including confidentiality aspects and property rights;
  • The rules of the outgoing European representative after the end of the agreement to forward to the manufacturer or incoming European representative
  • Any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a medical device.

In order to designate an EAR, an agreement should be signed between manufacturer and European Representative against the obligations present in the Regulation (EU) 2017/745 Article 11 or Regulation (EU) 2017/746 Article 11 with respect to the medical devices applicable.

Brexit Effects on European Authorized Representative

Want to keep selling the products in UK & Europe? Brexit is definitely affecting the scenario of appointing Authorized Representative.

If you are a Non-EU Manufacturer, then yes, you will have to keep 2 authorized representatives – One for Europe (the one situated in Europe) & One for UK (the one situated in UK).

If you are a manufacturer situated in UK and wants to keep selling the products in Europe, you will have to appoint one European Authorized Representative for your company.

Also, are you a Non-EU based manufacturer and appointed UK based Representative before Brexit? If you want to continue the sale of the product in European market then yes, you will also have to switch your European Authorized Representative and appoint the EU based Representative.

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.

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.

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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.

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