How it is created — REG-REC-019 EU Authorised Representative (Art. 19)

1. Why an EU manufacturer still writes this

Most small EU manufacturers conclude that Art. 19 does not apply to them, and stop there. The record exists so that an auditor sees the article was considered and reasoned, not missed — and so the conditions that would change the answer are written down while they are still hypothetical.

That is why the example has two parts: the determination everyone files, and the mandate only some need.

2. Part 1 — the applicability determination

1. State where the manufacturer is established and under whose name products are placed on the Union market. Those two facts decide the article.
2. Record the determination in one sentence, with a date and a signature.
3. Write the watch items. The realistic triggers are: selling a non-EU OEM's products under that OEM's brand, relocating establishment outside the Union, or a group restructuring that moves the legal entity that places products on the market.
4. Note the converse case explicitly, because it is the more expensive mistake: importing and rebranding a non-EU product under your own name makes you the manufacturer, with the full obligations. An authorised representative does not substitute for that, and neither does a supplier's declaration.
5. Tie the re-check to the annual management review, so the determination cannot silently age.

3. Part 2 — the written mandate, where one is required

1. Identify the parties and the products precisely. Product families with an annex listing models and firmware series, updated by written notice, ages better than a fixed list in the body.
2. Copy the minimum tasks from Art. 19(3) rather than paraphrasing them: keep the Declaration of Conformity and technical documentation at the disposal of market surveillance authorities for at least ten years after the product is placed on the market; provide information and documentation on a reasoned request, in a language the authority understands; cooperate on actions to eliminate risks.
3. State the manufacturer's side too. The representative can only perform those tasks if it receives the current Declaration of Conformity, technical documentation, SBOM references and support-period statements by the time each product is placed on the market — and prompt notice of vulnerabilities, incidents, corrective actions and recalls.
4. Draw the limits. Design and development obligations under Art. 13(1) and the vulnerability-handling duties under Annex I Part II stay with the manufacturer. A mandate that appears to transfer them is misleading and will not survive scrutiny.
5. Handle term and termination so that obligations continue for products placed on the market during the term.
6. Require the representative's name and address in the technical documentation, on the Declaration of Conformity, and on the product or its accompanying documentation.
7. Have it reviewed by legal counsel. This part is a contract, not a form.

4. Done when

• The determination is signed, dated and filed, with concrete watch items.
• Where a mandate exists: it is signed by both parties, the product annex is current, and a hand-over log records which document versions were transmitted and when.
• Both parties hold copies, and the product technical documentation references the mandate by ID.

5. Common mistakes

Treating an EU distributor or importer as an authorised representative without a written mandate. Believing an AR relieves the manufacturer of Annex I duties. Letting the product annex fall out of date, so the mandate no longer covers what is actually shipping.

6. In TRA Studio

Keep this record with the organisation rather than a single product, and reference it from each product's technical documentation. The determination's watch items are worth carrying as an assumption on the product, so a change of sourcing or branding surfaces the review rather than passing unnoticed.