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Across 6 directives — TSD, LVD, EMC, RED, PPE, Machinery

CE MarkingCE

CE marking is the manufacturer's self-declaration that a product meets all applicable EU rules. Get it wrong and the product is not legally on the market — even with the symbol. Regonance builds the technical file and Declaration of Conformity.

6 directives
TSD · LVD · EMC · RED · PPE · MD
Self-declaration
Route (v1)
Tech file + DoC
Per product
Amazon EU
Delisting risk
Who it affects

The concrete categories in scope

Sellers of electronics, toys, machinery, radio / wireless devices, PPE and low-voltage equipment. Amazon EU sellers in these categories (delisting risk). Agencies managing conformity across hardware clients.

Requirements

What CE obliges you to do

Obligation 1 of 3

Identify every applicable directive

A product may fall under several (e.g. a wireless toy: TSD + EMC + RED). Each directive has its own conformity route.

CE · obligation 1readiness
Directivesidentified
Technical filecompiled
Across 6 directives — TSD, LVD, EMC, RED, PPE, Machinerysource-traced
Obligation 2 of 3

Compile a technical file + run conformity assessment

Essential-requirements evidence, harmonised-standards test reports, per the applicable directives.

CE · obligation 2readiness
Test reportslinked
DoCsigned
Across 6 directives — TSD, LVD, EMC, RED, PPE, Machinerysource-traced
Obligation 3 of 3

Sign the EU Declaration of Conformity + affix the mark

A signed DoC and correctly affixed CE mark — self-declaration route for most consumer categories.

CE · obligation 3readiness
Markaffixed
Standardsmapped
Across 6 directives — TSD, LVD, EMC, RED, PPE, Machinerysource-traced
Timeline

Key dates and what they trigger

In force

Standing requirement

CE marking is required before placing in-scope products on the EU market — no transition period.

Ongoing

Marketplace enforcement

CE evidence increasingly required to list on Amazon EU and other marketplaces in scope categories.

Note

UK recognition

The UK recognises CE for most consumer goods; UKCA is voluntary for those categories.

Before → after

From exposed to audit-ready

Six readiness checks Regonance turns from gap to source-traced for CE.

Directives
unknownidentified
Technical file
nonecompiled
Test reports
missinglinked
DoC
unsignedsigned
Mark
not affixedaffixed
Standards
unmappedmapped
How Regonance helps

What the platform does for CE

Available on Growth, Pro and Agency (self-declaration route).

Capability 1

Detect applicable directives

Heuristic applicability check per product — TSD, LVD, EMC, RED, PPE (Cat. I) and MD (non-Annex IV) — with the rationale.

workspace · CEcapability 01
Technical filecompiled
Test reportslinked
Regonance outputsource-traced
Capability 2

Build the technical file

Section-by-section structure per EN ISO/IEC 17050-1, with test-report and evidence slots.

workspace · CEcapability 02
DoCsigned
Markaffixed
Regonance outputsource-traced
Capability 3

Generate the signed DoC

Append-only Declaration of Conformity, versioned per change to the underlying file.

workspace · CEcapability 03
Standardsmapped
Directivesidentified
Regonance outputsource-traced
Common gaps we flag

The gaps we see most often on CE

  • Wrong or missing directive applicability for the product
  • Incomplete technical file (no risk analysis, no design data)
  • Missing harmonised-standard test reports linked to the file
  • Unsigned EU Declaration of Conformity
  • CE mark incorrectly affixed, wrong size, or absent on packaging
findings · CEtop gaps
gap 01Wrong or missing directive…
gap 02Incomplete technical file …
gap 03Missing harmonised-standar…
Remediation queuedsource-traced
Evidence over verdicts

Every CE finding is source-traced — what the gap is, where it came from in your inputs, and the remediation step. A readiness report, not a verdict.

FAQ

CE questions, answered

Which products need CE marking?

Products covered by EU harmonisation legislation: electronics, toys, machinery, radio equipment, PPE, low-voltage equipment and more.

Can I self-declare CE?

For most consumer categories, yes — the self-declaration route. Some products (PPE Cat. II/III, Annex IV machinery) require a notified body — out of scope for v1.

What is an EU Declaration of Conformity?

A signed manufacturer document listing the applied directives and standards, declaring the product meets essential requirements.

Does CE marking cover the UK?

The UK recognises the CE mark for most consumer goods; UKCA is voluntary for those categories.

Is a Regonance DoC legally sufficient?

It generates a structured DoC per EN ISO/IEC 17050-1 from your inputs; final responsibility rests with the manufacturer. Informational guidance, not legal advice.

Get an audit snapshot for CE

One workspace. Eight EU regulations. Source-traced findings, defensible reports.

AI-assisted informational guidance, not legal advice. Validate scope and obligations with a qualified advisor before acting; consult the consolidated text on EUR-Lex for the authoritative legal source.