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EU & UK market access

CE marking without the maze

Directives, harmonized standards, testing coordination, and technical documentation — handled end to end for EU and UK market access.

CE marking compliance documentation and product review

What this engagement covers

We map every applicable EU directive (and UK equivalent), select the right conformity assessment route (self-declaration vs notified body), build a lean test matrix, coordinate labs, and assemble the Declaration of Conformity and technical file so you can place products on the market with confidence.

Best fit for

  • Hardware OEMs launching in the EU or UK for the first time
  • Teams stuck between LVD, EMC, RED, Machinery, and RoHS overlaps
  • Importers needing EU / UK Authorized Representative support
  • Products changing design, radio, or power architecture mid-certification

What's included

  • Directive & regulation applicability matrix by SKU
  • Conformity assessment module selection (Annex routes)
  • Gap analysis against design, BOM, and existing reports
  • Lab RFQ, scheduling, failure triage, and retest strategy
  • DoC / UK DoC, technical file structure, and labeling review
  • GPSR / economic operator obligations when applicable

Product types we support

Scope changes by product architecture — these are the classes we regularly take through this pathway.

IT / AV & consumer electronics

Laptops, docks, displays, chargers, smart home hubs

Industrial controls & sensors

PLCs, I/O, gateways, measurement instruments

IoT & connected devices

Wi-Fi / BLE / cellular endpoints needing RED + LVD/EMC

Machinery & partly completed machinery

OEM machines, robot cells, conveyors

Power supplies & adapters

External PSUs, USB-C PD, DIN-rail supplies

Lighting & luminaires

LED drivers, fixtures, emergency lighting

Technical categories

Conformity routes we commonly use

Module A self-declarationNotified Body Type Examination (radio / machinery)Existing CB / NRTL reports leveraged into CE evidenceCombination of manufacturer + OEM module reports

Regions & schemes

Market access is scheme-specific. We map filings and evidence to the regions you actually sell into.

European Union / EEA

  • •CE marking
  • •EU DoC
  • •EUDAMED/GPSR where applicable
  • •Notified Body when required

United Kingdom

  • •UKCA
  • •UK DoC
  • •UK Responsible Person
  • •Designated standards

Switzerland / Turkey (related)

  • •Recognition pathways assessed case-by-case

Directives & regulations

2014/35/EU — LVD

Electrical safety for AC 50–1000 V / DC 75–1500 V equipment

2014/30/EU — EMC

Emissions and immunity for apparatus

2014/53/EU — RED

Radio equipment: spectrum, EMC, and safety

2006/42/EC / Machinery Regulation (EU) 2023/1230

Machinery and safety components

2011/65/EU — RoHS

Restricted substances in EEE

GPSR (EU) 2023/988

General product safety for consumer products

Key standards

StandardFocus
EN IEC 62368-1Audio/video, IT and communication technology equipment — safety
EN 61010-1Safety requirements for electrical equipment for measurement, control, and laboratory use
EN 60335-1 (+ parts)Household and similar electrical appliances — safety
EN 55032 / EN 55035EMC emission / immunity for multimedia equipment
EN 301 489 / EN 300 328Radio EMC and wideband transmission systems
EN ISO 12100Machinery — risk assessment and risk reduction

Marks & program keywords

CEUKCALVDEMCREDMachineryRoHSGPSR

How we work

One clear path from classification to market-ready evidence.

Step 1

Classify

Product family, intended use, and economic operator role

Step 2

Scope

Directives, standards, and assessment modules

Step 3

Evidence

Testing, construction review, and file build

Step 4

Declare

DoC signing readiness and post-market surveillance prep

Engineering notes

We separate “must-test” vs “can-reuse” evidence so you do not re-run every clause when a radio module or PSU already has a valid report.

Technical files are structured for market surveillance: risk assessment, standards list, test reports, drawings, labeling, and DoC traceability.

Directive map you can defend

Fewer redundant tests

Audit-ready technical file

Ready to scope CE Marking?

30-minute consultation with Hazloc Labs — bring your product type, target markets, and any existing reports.

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