Legal path
This section does not redefine the Regulation — it translates it into obligations, evidence and control points that belong to Legal. Every page links to the canonical definition in The CRA framework.
Master table of obligations
| Obligation | Legal basis | Deadline | Evidence expected | Page |
|---|---|---|---|---|
| Qualify the product as a PDE | Art. 2, 3 | 11/12/2027 | Signed qualification sheet | Scope |
| Determine the criticality class | Annexes III, IV | 11/12/2027 | Classification sheet | Classes |
| Choose the assessment route | Art. 32, Annex VIII | 11/06/2026 | Notified body contract | Assessment |
| Compile the technical documentation | Annex VII | 11/12/2027 | Complete file, SBOM included | Technical documentation |
| Draw up the EU declaration of conformity | Annex V | 11/12/2027 | Signed declaration | Declaration |
| Affix the CE marking | Art. 30 | 11/12/2027 | Conformity review record | CE marking |
| Report within 24 h / 72 h / 14 d | Art. 14 | 11/09/2026 | Register + platform acknowledgements | Reporting |
| Determine and publish the support period | Art. 13, Annex II | 11/12/2027 | Register + statement to the buyer | Support |
| Provide information to the user | Annex II | 11/12/2027 | Notice shipped with the product | User information |
| Retain file and declaration | Art. 13, 31 | 11/12/2027 | Evidence vault + audit log | Retention |
What Legal must obtain from Cyber
- the SBOM, validated and signed, per product and per version, in the agreed format;
- the documented cybersecurity risk assessment;
- the vulnerability handling log and the VEX statements justifying uncorrected vulnerabilities;
- an operational coordinated disclosure policy with a live point of contact;
- security test reports;
- a description of the update distribution mechanism;
- the technical grounds for the support period chosen;
- in an incident, the “actively exploited” qualification, within two hours.
What Legal must supply to Cyber
- the regulatory classification of each product and the assessment route chosen;
- the licence policy and the list of prohibited licences;
- the supplier clauses negotiated and the commitments obtained;
- the decision on SBOM disclosure to customers;
- the decision to report and the approved wording;
- the support period committed contractually.
These exchanges, with deadlines and formats, are formalised in Legal ↔ Cyber interface.
The control point that matters
One thing must be non-negotiable on the Legal side: a formal right of veto over placing on the market until the fifteen points of the checklist are ticked. Without that gate, technical documentation gets assembled after the fact — which is exactly what market surveillance is looking for.
In this section
Legal
CE marking and technical documentation: the internal process
Who compiles, who reviews, who signs. The approval workflow, the market gate and the conformity review record.
Legal
EU declaration of conformity
Mandatory content under Annex V, the simplified form in Annex VI, language requirements, a ready-to-use template and the update rules.
Legal
Reporting duties: the legal decision
When the 24-hour clock starts, who decides, how to document the decision to report or not, and how to organise legal on-call cover.
Leadership
Exposure and risk register
Quantifying administrative, commercial and contractual exposure; keeping a compliance risk register; anticipating the effect on acquisition due diligence.
Legal
Supplier and customer contract clauses
The clauses to require upstream so you can meet your own deadlines, those to negotiate downstream, and the special case of free components for which no contract exists.
Legal
Intellectual property and licensing
The licence policy enforced in CI, the exception process, the register, attribution deliverables and preparing for customer audits.
Legal
Turning the support period into commitments
From the text of the Regulation to the terms and conditions: the mandatory statement to buyers, desynchronisation with suppliers, end-of-life policy and the register.
Legal
Information and instructions to the user (Annex II)
The ten mandatory items to supply with the product, the cybersecurity notice template, language requirements and the retention period.
Legal
Evidence retention
Which artefacts to keep, for how long, under what integrity guarantees, and the annual retrieval exercise that alone proves the arrangement works.
Legal
Pre-market checklist
Fifteen points, one page, printable and signable. The document that gives Legal's veto over commercialisation its substance.