Conformity assessment — selected routes under CRA, RED, machinery and MDR
Selected conformity-assessment routes and category checks under CRA, RED, machinery and MDR, with the evidence needed to justify the route for a product.
By CenitiaUpdated
Module letters are not a universal menu. The applicable act defines the available combination. CRA uses A, B+C and H; Machinery Regulation adds G for specified routes. MDR uses its own Annex IX/X/XI procedures. Do not import B+D, B+E or B+F from another regime into CRA.
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.
Part A, Part B and other machinery
From 20 January 2027, Annex I Part A uses B+C, H or G with a notified body. Part B may use A where applicable harmonised standards/common specifications cover all relevant essential requirements; otherwise B+C, H or G. Machinery outside Annex I uses A without a blanket complete-harmonised-standards prerequisite. Module E, B+D and H1 are not alternatives listed in Article 25.
Conformity assessment
For Article 3(1) requirements, Article 17(2) permits A, B+C or H. For Article 3(2)/(3), Article 17(3) permits A, B+C or H where applicable OJ-listed harmonised standards are fully applied; absent/partially applied standards, Article 17(4) requires B+C or H. Check exact editions, scope and OJ restrictions. EN 18031 citations under 2025/138 carry limitations; neither EN 18031 nor ETSI EN 303 645 automatically gives CRA presumption of conformity.
Device risk-class assessment
Plain Class I uses the applicable Annex II/III technical documentation and self-declaration. Is, Im and Ir require limited-scope NB assessment under the relevant IX/XI provisions. IIa routes include Article 52(6) documentation with permitted NB alternatives, including Annex XI sections 10/18. IIb and III use Annex IX OR Annex X combined with Annex XI, not a mandatory IX+X combination. Confirm device-specific and special-procedure conditions; include NB/certificate in DoC where applicable.
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
FAQ
Frequently asked questions
Does an AI draft or QR verification prove conformity?
No. The manufacturer must establish scope and satisfy applicable requirements using actual evidence. QR verification records issuance, not product certification.
What information must be checked for this product?
Confirm intended use, role, market/date, final configuration, dated specifications, assessment route and evidence scope. Record unresolved questions and a real reviewer decision.
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