CE Marking 101 — essential requirements and conformity evidence
A concise overview of RED marking and declaration rules, CRA declaration requirements, and the product evidence needed to support a manufacturer’s CE claim.
By CenitiaUpdated
CE marking is the manufacturer’s declaration under applicable harmonisation acts, not a generic quality award. Establish scope, essential requirements, assessment route and technical evidence first. The app’s signature or QR record does not replace those steps.
RED: CE marking and the notified-body number
Article 20(3) requires the NB identification number following CE when the Annex IV full-quality-assurance procedure is used. NB participation in type examination does not alone trigger that CE-adjacent number. Manufacturer documentation retention is Article 10(4); authorised-representative retention is Article 11(2)(a).
RED: declaration content
Article 18 and Annex VI govern the full EU DoC. Annex VII permits simplified DoC only with a functioning internet address providing the full text. Record manufacturer/product identity, actual applied standards/specifications, relevant NB and certificate where applicable, and authorised signatory details. Article 17 addresses assessment, not the DoC content obligation.
CRA: 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
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.
Continue reading
Related guides
reference
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.
4 min read
reference
Common CE marking errors — scope, assessment and evidence
Common pitfalls in CE marking, representative mandates, assessment routes and regulatory penalties, with primary references and product-evidence checks.
4 min read
guide
When you need a Notified Body — the EU CE marking decision guide
Selected RED, CRA, machinery and MDR route conditions that can require a notified body, with classification and evidence checks for the actual product.
4 min read
tutorial
Coordinated Vulnerability Disclosure Policy for Hardware Manufacturers
Build a usable hardware vulnerability disclosure policy with intake owners, safe testing boundaries and a security.txt example.
4 min read
Put this into practice
Free tools & references
- Do I need a Notified Body?Find out, per regulation, whether a Notified Body is required.Open tool →
- EU Directive SelectorDescribe your product and find which EU directives and regulations apply.Open tool →
New to the terminology? Browse the compliance glossary — plain-English, citation-backed definitions of every term above.