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:
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:
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.
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.
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.
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.
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-
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.