Ensure any authorised representative mandate covers the minimum statutory tasks

Article 18(1) provides that a manufacturer may, by a written mandate, appoint an authorised representative (AR).

Article 18(2) sets out what cannot be delegated to the AR — namely:

The obligations laid down in Article 13(1) to (11), Article 13(12) first subparagraph, and Article 13(14) shall not form part of the authorised representative's mandate.

This means the core design, development, production, vulnerability handling, and series conformity obligations remain with the manufacturer.

Article 18(3) requires the mandate to allow the AR to perform at least:

(a) keep the EU declaration of conformity referred to in Article 28 and the technical documentation referred to in Article 31 at the disposal of the market surveillance authorities for at least 10 years after the product has been placed on the market or for the support period, whichever is longer;

(b) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product with digital elements;

(c) cooperate with the market surveillance authorities, at their request, on any action taken to eliminate the risks posed by a product with digital elements covered by the authorised representative's mandate.

• Non-EU manufacturers who appoint an EU-based AR to act as their EU point of contact
• EU manufacturers who optionally appoint an AR

Non-EU manufacturers without an EU establishment should consider whether an AR appointment is necessary to ensure market surveillance authorities can reach them. Where an importer is established in the EU and can fulfil these functions, a separate AR appointment may not be required — but the importer route has different obligations (see OBL-ART19-01 to OBL-ART19-07).

1. Draft a written mandate identifying the AR and listing the minimum tasks
2. Confirm the mandate explicitly grants the AR access to or custody of the EU DoC and technical documentation
3. Keep a copy of the mandate and be prepared to provide it to market surveillance authorities on request (Art. 18(3) first paragraph)
4. Do not include language purporting to delegate design, development, or production obligations to the AR — such clauses would be void

• Signed written mandate specifying the AR's authority
• Contact details and establishment documents for the AR
• Internal process for providing the AR with current technical documentation and EU DoC at all times