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Creating a CRA Market-Access Checklist for Non-EU Vendors

A practical pre-market checklist for non-EU manufacturers and EU importers covering CRA roles, conformity evidence, CE marking, declarations, identification, support, traceability and escalation.

IN BRIEF

The checklist should operate as a release gate rather than a document folder. Every item needs an owner, evidence reference, status and escalation path so that missing or inconsistent CRA information stops market placement before products reach the Union market.

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1. Confirm the Product and CRA Scope

Identify the exact product, model, version and intended purpose and confirm that the CRA applies. Market-access evidence should be product specific rather than based on a general supplier statement.

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2. Identify the Legal Manufacturer

Record the non-EU legal entity that meets the CRA manufacturer definition and confirm that its identity matches product and conformity documentation.

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3. Identify the EU Importer

Record the EU-established person that will place the product on the Union market and confirm that it accepts the Article 19 role and operational responsibilities.

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4. Check the Conformity Assessment Route

Confirm which Article 32 conformity procedure applies and that the manufacturer has completed it. Escalate products where the route is unclear or inconsistent with classification.

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5. Confirm Technical Documentation Exists

The importer must ensure that the manufacturer has drawn up technical documentation. Record where the evidence is controlled and how authority requests will be supported.

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6. Verify CE Marking

Check that the product bears the required CE marking and that the marking is consistent with the product and conformity evidence.

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7. Verify the EU Declaration of Conformity

Confirm that the declaration accompanies the product as required, identifies the relevant product and manufacturer and aligns with the conformity route.

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8. Verify Annex II Information and Instructions

Check the required user information and instructions, including the appropriate language for the target market and required security and support information.

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9. Verify Manufacturer Identification

Confirm the required manufacturer identity and contact information is present and consistent across the product, packaging and documentation.

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10. Add and Verify Importer Identification

Ensure the importer provides its required name and contact information through the permitted presentation route without obscuring manufacturer information.

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11. Check Support-Period Information

Confirm the support-period end date information required from the manufacturer is available and consistent with product documentation and customer-facing materials.

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12. Confirm Vulnerability and Security Contacts

Ensure the importer knows how to reach the manufacturer's security contact and how internal staff should escalate vulnerabilities or significant cybersecurity risk.

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13. Create Article 23 Traceability Records

Link the product to the upstream supplier and downstream economic operators where available and configure retention so the information remains presentable for the required 10-year periods.

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14. Check for Article 21 Role Changes

Before private-label sale or modification, determine whether the importer or distributor will place the product under its own name or trademark or substantially modify it. If so, manufacturer obligations may apply.

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15. Define the Non-Conformity Escalation

Document who can stop market placement, who contacts the manufacturer, how significant cybersecurity risk is assessed and when authorities or users must be informed.

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16. Approve Market Placement

Require a named approver to confirm that all mandatory evidence is complete before the product is placed on the market. Preserve the completed checklist with the product's market-access record.

REFERENCE DESK

Official sources

Read the full legal text and Commission material for precise wording, qualifications and updates.

Editorial review: 26 September 2026. Regulatory material can change; follow the official sources for current guidance.