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PRACTICAL GUIDANCE — NOT LEGAL TEXTNEEDS REVIEW

CRA scoping checklist

A structured checklist to document, product by product, whether and how the Cyber Resilience Act may concern you — questions linked to the official text, no verdict.

Prepared by regulation-cra.euUpdated 2 November 2026Version 1.0Not yet reviewed by a named expert

What it is for

This checklist helps manufacturers, importers and distributors record, product by product, the facts that matter when examining whether the Cyber Resilience Act (Regulation (EU) 2024/2847) may apply and in which role. Each question points to the provisions it is based on.

It deliberately produces no verdict. Its purpose is a dated, documented analysis that you, or an adviser, can review.

Good practice (recommendation, not a legal requirement)

Keep one completed checklist per product (or per version where versions differ in functionality or market), with the evidence behind each answer. This is good practice, not a requirement of the Regulation.

How to use it

  1. Use one copy per product or product version.
  2. For each item, read the cited provisions in the official text before answering.
  3. Record the answer, the evidence and the person who checked it.
  4. Mark an item as "Unclear" rather than guessing, and list these items for expert review.
  5. Date the checklist and review it when the product, its intended purpose, its market or its distribution model changes.

1. The product

What the text requires

The Regulation applies to products with digital elements made available on the market, the intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network Article 2(1).

2. Market and timing

  • 2.1 Is the product supplied for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge? — Article 3, point (22), Article 3, point (21)
  • 2.2 When was, or will be, each version first placed on the Union market — before or after 11 December 2027? — Article 71(2), Article 69(2), Article 69(3)
  • 2.3 Have changes made after placing on the market affected compliance with Part I of Annex I, or modified the intended purpose for which the product was assessed? — Article 3, point (30)

What the text requires

Products placed on the market before 11 December 2027 are subject to the requirements only if they undergo a substantial modification from that date (Article 69(2)). By way of derogation, the reporting obligations of Article 14 apply to all in-scope products placed on the market before that date (Article 69(3)), and Article 14 applies from 11 September 2026 (Article 71(2)).

3. Free and open-source software

Our interpretation

Recital 18 explains that the provision of free and open-source software that is not monetised by its manufacturers should not be considered a commercial activity, and that the circumstances of development or financing should not be taken into account. Recitals are not operative provisions: we recommend recording the concrete facts (pricing, paid support, monetisation, integration into monetised products) rather than relying on the licence alone.

4. Exclusions and other Union legislation

  • 4.1 Does Regulation (EU) 2017/745 (medical devices), Regulation (EU) 2017/746 (in vitro diagnostic medical devices) or Regulation (EU) 2019/2144 (type-approval of motor vehicles) apply to the product? — Article 2(2)
  • 4.2 Has the product been certified in accordance with Regulation (EU) 2018/1139 (civil aviation)? — Article 2(3)
  • 4.3 Is it equipment within the scope of Directive 2014/90/EU (marine equipment)? — Article 2(4)
  • 4.4 Was it developed or modified exclusively for national security or defence purposes, or is it specifically designed to process classified information? — Article 2(7)
  • 4.5 Is it a spare part replacing an identical component, manufactured to the same specifications? — Article 2(6)
  • 4.6 Do other Union rules address all or some of the same risks, and has a delegated act limited or excluded the application of the Regulation? — Article 2(5), first subparagraph, Article 2(5), second subparagraph
  • 4.7 Is the product classified as a high-risk AI system under Regulation (EU) 2024/1689? — Article 12(1)

5. Product category

6. Your role

  • 6.1 Manufacturer: you develop or manufacture the product, or have it designed, developed or manufactured, and market it under your name or trademark. — Article 3, point (13), Article 13, Article 14
  • 6.2 Importer: you are established in the Union and place on the market a product bearing the name or trademark of a person established outside the Union. — Article 3, point (16), Article 19
  • 6.3 Distributor: you make the product available on the Union market without affecting its properties, other than as manufacturer or importer. — Article 3, point (17), Article 20
  • 6.4 Do you, as importer or distributor, place the product on the market under your own name or trademark, or carry out a substantial modification? Does another person substantially modify it and make it available? — Article 21, Article 22(1)
  • 6.5 Has the manufacturer appointed an authorised representative? — Article 18

7. Record and review

Good practice (recommendation, not a legal requirement)

Record the reasoning and evidence for each answer, the date and the person responsible, and list the items marked "Unclear" for expert review. Revisit the checklist when delegated acts, implementing acts or official guidance are published.

Downloadable version

The Excel workbook and the Word document contain the same 25 items, with a guidance note for each item and empty Status, Owner and Notes columns to fill in.

DOWNLOAD — VERSION 1.0

Same content, ready to fill in

Limits. This checklist is an orientation and documentation aid prepared by regulation-cra.eu. It is not legal advice, does not determine whether Regulation (EU) 2024/2847 applies to a product and does not establish compliance. It reflects the text published in the Official Journal with its corrigenda; delegated and implementing acts, harmonised standards and official guidance may add detail. Only the texts published in the Official Journal of the European Union are authentic.