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Any manufacturer of medical devices or in vitro diagnostics established outside the European Union must appoint an EU Authorized Representative — commonly referred to as an EC Rep — before placing their products on the EU market. This requirement is set out in Article 11 of Regulation (EU) 2017/745 (MDR) and applies regardless of the size of the manufacturer or the volume of products sold.
The question we receive most often from manufacturers outside Europe is not whether they need an EC Rep — they usually know they do — but what the role actually requires in practice, and what responsibilities the EC Rep takes on. The answer matters because choosing the wrong EC Rep, or appointing one without understanding the obligations involved, creates compliance gaps that surface during market surveillance or notified body audits.
What the EU Authorized Representative does under MDR
The EU Authorized Representative acts as the legal point of contact between the non-EU manufacturer and EU regulatory authorities. Under Article 11(3) of MDR, the EC Rep must be established in the EU and must be explicitly designated by the manufacturer in a written mandate. The mandate must define the scope — which products are covered — and the specific tasks the EC Rep is authorised to perform on the manufacturer’s behalf.
The core responsibilities of the EC Rep include: registering the manufacturer and the devices in EUDAMED (the EU database for medical devices); cooperating with national competent authorities during market surveillance and post-market activities; forwarding to the manufacturer any vigilance reports, field safety corrective actions, or requests for technical documentation received from EU authorities; and verifying that the EU Declaration of Conformity and the technical documentation required by MDR have been drawn up and kept up to date.
The EC Rep’s name and address must appear on the device label or packaging alongside the manufacturer’s details. If a device is recalled or subject to a field safety corrective action, the EC Rep is the entity that EU authorities will contact first.
Who needs an EU Authorized Representative
The obligation applies to manufacturers established in countries outside the EU, the EEA (Norway, Iceland, Liechtenstein), and countries with mutual recognition agreements with the EU covering medical devices. In practice, this means manufacturers in China, the United States, South Korea, Japan, India, Brazil, and most other markets need an EC Rep to sell into the EU.
Manufacturers in the United Kingdom need an EC Rep for the EU market (and a separate UK Responsible Person for the UK market) following Brexit. Switzerland had mutual recognition for medical devices under the old Directive 93/42/EEC, but the EU-Switzerland Mutual Recognition Agreement was not updated to cover MDR 2017/745 or IVDR 2017/746. Swiss manufacturers are therefore treated as third-country manufacturers: they must appoint an EU Authorized Representative before placing devices on the EU market. Spanish importers of Swiss-manufactured medical devices must also obtain an import licence from AEMPS, just as they would for products from any other non-EEA country.
Distributors and importers established in the EU do not need to appoint an EC Rep — the obligation is on the non-EU manufacturer. However, an EU importer who places a device on the market when the non-EU manufacturer has not appointed an EC Rep takes on the obligations of the manufacturer under MDR Article 16.
What MDR requires from the EC Rep: the practical obligations
The EC Rep must register in EUDAMED with its own Single Registration Number (SRN) before it can register devices on behalf of the manufacturer. The registration includes the EC Rep’s contact details, the mandate scope, and details of each device covered. EUDAMED is the central EU registry for medical device information and is publicly accessible for basic data.
Beyond EUDAMED registration, the EC Rep must be able to provide technical documentation and the Declaration of Conformity to competent authorities within the timeframes set by MDR — typically within 30 days of a request, or within 15 days for serious incidents. This means the EC Rep must have genuine access to the manufacturer’s technical file, not just a formal designation on paper.
In our experience, the most common gap in EC Rep arrangements is the lack of a functioning communication protocol between the manufacturer and the EC Rep for post-market surveillance reporting. The MDR requires the manufacturer to notify the EC Rep of vigilance events, field safety corrective actions, and periodic safety update reports. Without a documented procedure for this, the arrangement fails its first real test during an incident.
How to appoint an EU Authorized Representative: the process
The appointment requires a signed mandate agreement that specifies: the manufacturer’s identity and contact details; a complete list of devices covered (by device name and model, GMDN code, and risk class); the specific tasks delegated to the EC Rep; the term of the mandate; and the conditions under which either party can terminate the agreement.
The mandate must be signed before EUDAMED registration begins, since the EC Rep needs to reference the manufacturer in the registration. After registration, the manufacturer’s SRN and the EC Rep’s SRN are linked in EUDAMED, and each device is registered under both identifiers.
Selecting an EC Rep is a regulatory decision, not a procurement exercise. The EC Rep takes on legal liability for the accuracy of device registrations in EUDAMED and for the completeness of post-market surveillance cooperation. A service provider who offers EC Rep services at very low cost without technical review of the device documentation is unlikely to fulfil these obligations adequately.
What happens after appointing an EC Rep
Once the mandate is signed and EUDAMED registration is complete, the devices can be placed on the EU market. The EC Rep’s responsibilities are ongoing: EUDAMED registration data must be kept current, post-market surveillance reports must be reviewed as they are received, and any change in the device (new model, change of classification, updated technical documentation) must be reflected in the EUDAMED registration.
If the manufacturer terminates the EC Rep mandate, the devices cannot be placed on the EU market until a new EC Rep is appointed and registered in EUDAMED. There is no grace period. For manufacturers with active distribution in the EU, an EC Rep gap means immediate non-compliance.
Once you have appointed an EU Authorized Representative and completed EUDAMED registration, the next area to review is the technical documentation under MDR that importers must be able to provide to competent authorities on request. For context on recent changes affecting notified body timelines, see our article on Regulation 2026/977 and maximum timelines for notified bodies.
If you are a manufacturer outside the EU looking to appoint an EU Authorized Representative for your medical devices or in vitro diagnostics, our regulatory services team can act as your EC Rep and manage EUDAMED registration, technical documentation review, and ongoing post-market surveillance cooperation. For a first conversation about your specific product portfolio, contact us here.