CRA December 2027 readiness — scope, assessment and evidence checks

Build separate plans for reporting already applicable from 11 September 2026 and the main product obligations applicable from 11 December 2027. Distinguish existing units, new placing and substantial modifications.

Existing products and modifications

Distinguish products first placed before 11 December 2027, later substantial modifications, and Article 14 reporting. Article 69(2)/(3) does not automatically apply every Annex I and Article 13 duty to every legacy unit. Article 14 expressly also applies to relevant legacy products. Assess the particular product/version and placing date.

Manufacturer duties, lifetime and retention

Document cybersecurity risk assessment and technical evidence; do not infer conformity from an AI draft. Article 13(8): determine support with expected use and reasonable user expectations; normally at least five years, or shorter where expected use is shorter. Consider longer expected use. Article 13(13): retain technical documentation and DoC for ten years after placing on the market or the support period, whichever is longer. Annex VII specifies technical-documentation content.

Conformity assessment A, B+C and H

Annex VIII offers internal control (A), EU-type examination plus conformity to type (B+C), and full quality assurance (H). Standard products may use A. Important Class I A depends on Article 32(2) full coverage through applicable harmonised standards, common specifications or qualifying certification; otherwise B+C or H. Class II uses B+C or H under Article 32(3). Article 32(5) allows qualifying important free/open-source software with public technical documentation to use A. Critical products require assessment of Article 8 certification conditions; absent the mandated suitable scheme conditions, Article 32(4) provides B+C or H. Classify the main product function against Annexes III/IV and implementing technical descriptions 2025/2392, not a component name alone.

EU declaration of conformity

Article 28 governs the manufacturer EU declaration of conformity, using Annex V information. Annex VI is the simplified declaration; its internet address must provide the full text. State only standards/specifications actually applied and assessments actually performed. The declaration does not transfer manufacturer responsibility to the drafting tool.

Evidence to keep with the product

Record the intended purpose, responsible economic operator, target market, first placing date and exact hardware/firmware configuration. For each applicable requirement, link the actual test or assessment record, dated standard/specification, scope and reviewer decision. Proposed controls and supplier marketing statements are not evidence that the final configuration has passed an assessment.

Separate an open question from a completed assessment. A report outside the laboratory's relevant scope, a different firmware build or an unverified exemption needs a reasoned decision before it supports a declaration. Keep original evidence and the issued declaration alongside any AI-assisted working draft.

Using Cenitia for this work

Cenitia assists with a limited regulatory catalogue and draft documents. The manufacturer must confirm applicability, actual applied specifications and completed assessment procedures. AI scores are quality signals, not a probability of conformity. Source monitoring raises a review prompt when validated source text changes; it does not automatically verify amendments, update the corpus or monitor every national rule and OJ standard edition. Public QR verification records issuance, not product certification.

Review status

This guide was substantively corrected by Cenitia on 2 October 2026 using the primary references below. It is an editorial summary, not an authoritative legal quotation or an independently signed expert opinion. Product-specific and licensed-standard questions remain subject to a real technical review.

Primary references

• Primary source 1