What is an ‘Authorised Representative’?

In the case of an EU AR, the representative needs to be based in one of the 27 members states (from 1st January 2021 the UK became a ‘third country’ so an EU AR could no longer be located in the UK).

The CE mark is a requirement for the majority of product types that are being placed on the EU market. The CE declaration of conformity (also referred to as EC declaration of conformity) requires certain key information to be stated on it such as the business name, person responsible, product names / model number and legislation applied.

Is it mandatory to appoint an EU Authorised Representative?

Under the Market Surveillance legislation EU 2019/1020 released in July 2019 all items falling under the scope of union harmonisation legislation (as identified in Article 4, paragraph 5 of the legislation) will need to have an EU economic operator and business name and address for surveillance purposes.

An EU economic operator can be in the form of an:

• EU based importer
• EU based distributer
• EU based fulfilment service provider
• EU based Authorised Representative

Listed below are a few obligations of an EU economic operator (the full list can be found in the Market Surveillance legislation):

1. Verify that the EU declaration of conformity or declaration of performance & technical file have been drawn up if applicable to the product
2. Ensure that the technical documentation can be made available to authorities upon request.
3. Cooperate and liaise between the Market Surveillance authorities and the manufacturer when a reason request for information is required to demonstrate conformity.
4. The name and the contact details (including the address) of the EU Economic Operator should be indicated on the product, packaging or accompanying document.

GPSR – EU General Product Safety Regulation 2023/988

Products within the scope of EU GPSR do not require the CE Mark but since the regulation came into place on 13th December 2023, taking place of the EU GPSD, there are changes that manufacturers need to be aware of. Under the GPSR, products must have a ‘producer’ who takes responsibility for placing the product on the market. A producer can be a manufacturer based within the EU, an importer based within the EU or a ‘manufacturer’s representative’ (Authorised Representative) based within the EU if the manufacturer is based outside.

 “an indication, by means of the product or its packaging, of the identity and details of the producer”
Or in other words there needs to be the name and address of an EU based manufacturer’s representative or importer accompanying the product, thus in effect extending the requirement for an identifiable economic operator within the EU to most simple consumer products.

Check out our Resources page for more information on EU General Product Safety Regulation 2023/988 (GPSR).

EU Authorised Representative for Medical Devices

It is mandatory for manufacturers of medical devices based outside the EU to appoint an EC Rep, also known as an EU Authorised Representative. The obligations of an EU Authorised Representative for medical devices differ from the obligations outlined in the Market Surveillance legislation EU/2019/1020.

Listed below are a few obligations of an EC rep/ medical EU Authorised Representative, for the full list of obligations see the MDR:

1. Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
2. Verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
3. Ensure the technical documentation can be made available to authorities upon request.
4. Comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
5. Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

Can I change the EU Authorised Representative?

The simple answer is yes!
The EU AR service can be transferred to a new EU AR provider.  If this is something you would like to do, contact us and we can help you with this process.

How can we help you?

Comply Express provides the EU Authorised Representative service for a number of product types. We will act as the official point of contact between you and the EU Market Surveillance Authorities and comply with any registration requirements layout in the applicable legislation.  Our EU address can be utilised on your product, packaging or accompanying documents.

*Please note certain product categories may require additional information.

Additional Support and Services

Need help with your technical file, declaration of conformity or product labelling? Our team of compliance engineers can assist you with the documentation your product needs to meet market legislations.

Product Compliance Management – Our SmartCert software guides you through the compliance journey. From identifying the applicable legislation to on-going legislative monitoring to ensure up-dates and changes aren’t missed which is a very common mishap which can lead to devastating consequences.
Visit our features page for more information.

We provide the UK Responsible Person Service for manufacturers based outside of the UK placing medical devices onto the UK market.
Visit our UK Responsible Person page for more information

FAQ
What is an EU economic operator?  

• Manufacturer established in the EU
• An importer based in the EU
• An authorised representative based in the EU
• A fulfilment service provider established in the EU

What is an EU Authorised Representative?

An EU Authorised Representative (EU AR) is a natural or legal person established within the EU who is appointed by a non-EU based manufacturer to act on their behalf in fulfilling the obligations under the applicable EU product legislation.

What is an EC-Rep?

For medical devices you may have seen various terms being used and wondered if they all mean the same. The following terms all have referenced to the EU Authorised Representative for medical devices:

• EC REP symbol or EC-REP symbol – this is used to identify the authorised representative
• Authorised Representative – referred to in the MDR
• Authorized Representative in the European community – referred to in the EU Harmonized Standard EN ISO 15223-1

I’m placing a product on the Northern Ireland market do I need an EU authorised representative?

• If you are placing a product onto the Northern Ireland market and meet the below requirements you will need an EU Authorised Representative:
• The product being placed on the market is applicable to a directive or regulation that requires an economic operator within the EU or NI
• You are not based in the EU or NI
• You do not have a manufacturer, importer or fulfilment service provider based in the EU or NI to act as the economic operator or in the case of the EU GPSR, an EU based producer.

How do I get started?

Simply contact Comply Express  by email  or phone to enquire further