EC REP (EU Authorised Representative): Obligations, Liability, Cost and Process
Which manufacturers outside the EU need an EC REP, what it takes on, what it is liable for and what it costs at SPACEGOATS.
An EC REP (EU authorised representative) is a person or company established in the EU that a manufacturer from outside the EU appoints in writing to carry out specific legal obligations on its behalf. You need an EC REP if you are based outside the EU and nobody else in the EU, such as an importer, is responsible for your product. For medical devices it is always mandatory. The EC REP is the contact point for authorities, keeps the conformity documents available and is named with name and address on the product or its packaging. At SPACEGOATS the EC REP service costs EUR 249 per month (excl. VAT, annual contract).
Manufacturers based in Germany or any other EU member state do not need an EC REP: they are themselves the responsible economic operator in the EU. If you import products from a non-EU manufacturer, you are responsible as the importer, and an EC REP does not replace your own obligations.
EC REP at a glance: cost, obligations, process
| Question | Short answer |
|---|---|
| What is an EC REP? | An EU-based authorised representative that performs tasks for a non-EU manufacturer under a written mandate (term defined in Art. 3 of the Market Surveillance Regulation (EU) 2019/1020). |
| Who needs one? | Non-EU manufacturers of medical devices, always (Art. 11 MDR (EU) 2017/745). For CE products and consumer products under the GPSR, whenever no other economic operator in the EU is responsible. |
| What does it do? | Keeps the declaration of conformity and technical documentation available, answers authority requests, reports risks, and cooperates on corrective actions and recalls. |
| What is it liable for? | For the tasks in its mandate. For medical devices it is jointly and severally liable with the importer and manufacturer for defective devices (Art. 11(5) MDR). |
| How is it appointed? | Written mandate, hand-over of documents, name and postal address on the product, packaging or accompanying document, and in the online listing. |
| What does it cost? | At SPACEGOATS EUR 249 per month excl. VAT on an annual contract. The effort depends on product category, number of products and the state of the documentation. |
Who needs an EC REP?
Whether you need one depends on the EU legislation that applies to your product and on whether someone established in the EU is already responsible:
- Medical devices and in-vitro diagnostics: a manufacturer not established in the EU must designate a single authorised representative (Art. 11 MDR (EU) 2017/745, Art. 11 IVDR (EU) 2017/746). Having an importer does not replace it.
- CE-marked products such as toys, electrical equipment, radio equipment, machinery or personal protective equipment: since 16 July 2021, an economic operator established in the EU must be responsible for products covered by Art. 4 of the Market Surveillance Regulation (EU) 2019/1020. That can be an EU-based manufacturer, an importer, an authorised representative or a fulfilment service provider.
- Consumer products without CE marking: since 13 December 2024 the same principle applies under Art. 16 of the GPSR (EU) 2023/988. Without a responsible economic operator in the EU, the product may not be placed on the market.
- Manufacturers established in the EU: no EC REP needed. You are the contact point for authorities yourself.
Obligations of the EC REP
The minimum tasks are set out in Art. 4(3) of the Market Surveillance Regulation (EU) 2019/1020. Anything beyond that is defined in the mandate:
- Verify that the EU declaration of conformity and technical documentation have been drawn up, and keep them available to authorities for the required period
- Provide authorities, on reasoned request, with all information and documentation in a language they understand
- Inform the authorities when there is reason to believe a product presents a risk
- Cooperate with the authorities and ensure corrective action such as withdrawals or recalls is taken
- For medical devices additionally: have a person responsible for regulatory compliance permanently and continuously at its disposal (Art. 15(6) MDR)
What is an EC REP liable for?
First and foremost, the EC REP is liable for the tasks in its mandate. Authorities can contact it, request documents and demand action without having to reach the manufacturer abroad.
Liability goes further for medical devices: under Art. 11(5) MDR the authorised representative is jointly and severally liable with the importer and manufacturer for defective devices. The new Product Liability Directive (EU) 2024/2853 also makes the authorised representative liable where the manufacturer is established outside the EU and there is no importer. It applies to products placed on the market from 9 December 2026.
Process: how an EC REP is appointed
- Check the obligation: which EU acts apply to the product, and is there already an importer or manufacturer established in the EU?
- Provide documents: EU declaration of conformity (for CE products), technical documentation, risk analysis, labels and instructions.
- Sign the mandate: a written authorisation defining the tasks the EC REP takes on. There is no official EC REP certificate.
- Update the labelling: name, registered trade name or trade mark and postal address and contact details on the product, packaging, parcel or accompanying document (Art. 4(4) Regulation (EU) 2019/1020). For medical devices the representative goes on the label, usually with the "EC REP" symbol from EN ISO 15223-1.
- Update online listings: for distance sales, Art. 19 GPSR requires the responsible person to be shown in the offer, on Amazon in the dedicated fields.
- Ongoing support: authority requests, incidents and recalls go through the EC REP.
EC REP cost: what the price depends on
SPACEGOATS offers the EC REP service for EUR 249 per month excl. VAT on an annual contract. The exact scope depends on three things: the product category (medical devices require more than consumer products under the GPSR), the number of products, and whether the declaration of conformity and technical documentation are already complete.
If documents are missing, we clarify that first in a compliance check. All packages and prices are listed on our product compliance consulting page.
EC REP and Amazon
Amazon asks for the manufacturer and the EU responsible person as separate listing attributes and shows them to buyers on the product page. If you would rather not run compliance, import and sales yourself: in the SPACEGOATS Amazon broker model we buy your goods and sell them through our own seller accounts, including VAT, EPR and GPSR handling.
EC REP: frequently asked questions
What is an EC REP?
An EC REP (EU authorised representative) is a natural or legal person established in the EU that a manufacturer from outside the EU appoints in writing to carry out specific legal tasks on its behalf. It is the contact point for market surveillance authorities and keeps the declaration of conformity and technical documentation available.
Who needs an EC REP?
Manufacturers outside the EU that sell medical devices, always (Art. 11 MDR). For CE products and consumer products under the GPSR, an economic operator established in the EU must be responsible, which can also be an importer or a fulfilment service provider. Manufacturers established in the EU do not need an EC REP.
What is an EC REP liable for?
For the tasks in its mandate, such as keeping documents available, informing authorities and cooperating on recalls. For medical devices it is jointly and severally liable with the importer and manufacturer for defective devices (Art. 11(5) MDR).
How is the EC REP labelled on the product?
Name, registered trade name or trade mark and postal address and contact details go on the product, its packaging, the parcel or an accompanying document. For medical devices the representative is shown on the label, usually with the "EC REP" symbol from EN ISO 15223-1.
Is there an EC REP certificate?
No. The basis is a written mandate between manufacturer and authorised representative, which is presented to authorities on request. SPACEGOATS issues this mandate when we take on the EC REP role.
What does an EC REP cost at SPACEGOATS?
EUR 249 per month excl. VAT on an annual contract. The scope depends on product category, number of products and completeness of the documentation and is agreed in the quote beforehand.