Distributor shown as AR
A distributor is not your Authorised Representative unless it holds a written mandate.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
EC REP marks the EU Authorised Representative on a medical device label. For a manufacturer established outside the EU, the label must identify it, and it is one of the most frequently checked items in market surveillance and marketplace reviews.
"EC REP" is the label used with the harmonised symbol for the authorised representative in the European Community / European Union. Under the MDR and IVDR that is the EU Authorised Representative: the single company established in the EU that a non-EU manufacturer has designated by a written mandate under Article 11.
Only that company can be shown as EC REP. The mandate must be accepted in writing by the Authorised Representative and covers at least all devices of the same generic device group (Article 11(2)). A distributor, importer, consultant or Notified Body is not your EC REP unless it holds that mandate.
The EC REP takes on defined legal tasks, including verifying the declaration of conformity and technical documentation, registering in EUDAMED and cooperating with authorities, and it can be jointly and severally liable for defective devices (Article 11(5)). See EU Authorised Representative under Article 11 for the full list.
Annex I, Section 23.2 of the MDR (Section 20.2 of the IVDR) requires the label to bear, where the manufacturer has its registered place of business outside the Union, the name of the Authorised Representative and the address of its registered place of business - in addition to the manufacturer's own name and address.
| Actor | On the label |
|---|---|
| Manufacturer | Name or registered trade name or trade mark, and address of the registered place of business |
| EU Authorised Representative | Name and address of its registered place of business, when the manufacturer is outside the EU |
| Importer | Name, registered trade name or trade mark, registered place of business and address - on the device, its packaging or an accompanying document (Article 13) |
EN ISO 15223-1 provides a harmonised symbol for the authorised representative in the European Community / European Union, commonly called "EC REP". Using the symbol next to the name and address is widely accepted and avoids translating the word "Authorised Representative" into every language.
Put the symbol directly next to the name and address of your EU Authorised Representative. No EU AR yet? Check your device →
A distributor is not your Authorised Representative unless it holds a written mandate.
After a change of AR, labels keep the old details beyond the agreed date.
A trading name or email is not the address of the registered place of business.
Label, instructions, declaration of conformity and EUDAMED show different AR details.
It identifies the EU Authorised Representative: the EU-established company designated by a non-EU manufacturer under Article 11 MDR/IVDR. The EC REP symbol is followed by that company's name and registered address.
Only the company that holds the manufacturer's written mandate as EU Authorised Representative under Article 11. The manufacturer designates a sole Authorised Representative, and the mandate covers at least all devices of the same generic device group. A distributor or importer cannot be shown as EC REP without that mandate.
Yes, where the manufacturer's registered place of business is outside the Union: its name and the address of its registered place of business are required on the label.
The harmonised symbol from EN ISO 15223-1 for the authorised representative in the European Community / European Union, used next to its name and address.
Yes. Under Article 13 the importer indicates its name, registered trade name or trade mark, registered place of business and address on the device, its packaging or an accompanying document.
Label transition after a change.
Keep label and EUDAMED data consistent.
MDR and IVDR classes.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. Before you sign a mandate, we tell you what the next step is.