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AMS Consultants
Accelerating safe market access

CE / UKCA Marking

To accurately reflect the regulatory nuances of both the European Economic Area (EEA) and the Great Britain (GB) markets, the page must clearly delineate between EU Directives/Regulations and UK Statutory Instruments.

Applicable regulation
  • 2006/42/ECMachinery DirectiveEU machinery and partly completed machinery
  • 2014/35/EULow Voltage Directive (LVD)Electrical equipment 50–1000 V AC / 75–1500 V DC
  • 2014/30/EUElectromagnetic Compatibility (EMC)Equipment that generates or is affected by EM disturbance
What is it?

CE / UKCA Marking, explained.

Navigating the dual requirements of the CE and UKCA marks can be legally overwhelming for many manufacturers. At AMS Consultants, we prioritise clarity by translating dense European Union Directives and United Kingdom Statutory Instruments into actionable engineering steps. We break down complex legal obligations, such as the Machinery Directive and the Medical Device Regulation, into clear design and safety parameters. This ensures your research, development, and manufacturing teams know exactly what to do without ever getting bogged down in regulatory jargon. Our compliance roadmaps are built on a foundation of absolute integrity. From identifying the correct Harmonised or Designated standards to compiling your comprehensive Technical File, every deliverable is evidence-led and rigorously peer-reviewed by our seasoned experts. We strive for excellence, ensuring your Declaration of Conformity is strictly aligned with the highest global safety standards and remains technically defensible to any Notified or Approved Body. Furthermore, we understand that compliance is too often viewed as a bottleneck, which is why we do not just audit; we collaborate. By functioning as an integrated extension of your team, we handle the heavy lifting of regulatory coordination and documentation. Our client-focused methodology is meticulously designed to optimise the conformity process, drastically reducing your regulatory risk and accelerating your safe market access across Europe, the United Kingdom, and the wider global market.

The process

How we deliver this service

A structured sequence runs behind every project so nothing is missed and the deadline stays in sight from day one.

01

Incorporate 'Clarity' through Technical Translation

Manufacturers are often overwhelmed by the dense legal jargon of legislative texts like the Machinery Directive (2006/42/EC) or the Medical Device Regulation (EU 2017/745). Navigating the dual requirements of the CE and UKCA marks can be legally overwhelming. At AMS Consultants, we prioritise clarity by translating dense EU Directives and UK Statutory Instruments into actionable engineering steps. We break down complex legal obligations into clear design and safety parameters, ensuring your R&D and manufacturing teams know exactly what to do without getting bogged down in regulatory jargon.

02

Embed 'Integrity' and 'Excellence' in Risk Assessment & Standard Selection

The foundation of both the CE and UKCA marks relies on the correct application of Harmonised (EU) and Designated (UK) standards. Misclassification can lead to product recalls or market delays. Our compliance roadmaps are built on a foundation of integrity. From identifying the correct Harmonised or Designated standards to compiling your Technical File, every deliverable is evidence-led and peer-reviewed by our seasoned experts. We strive for excellence, ensuring your Declaration of Conformity is strictly aligned with the highest global safety standards and is technically defensible to any Notified or Approved Body.

03

Highlight 'Collaboration' and 'Client-Focused' Market Access

Compliance is often viewed as a bottleneck that slows down product launches. We don't just audit; we collaborate. By functioning as an integrated extension of your team, we handle the heavy lifting of Notified/Approved Body coordination and documentation. Our client-focused methodology is designed to optimise the conformity process, drastically reducing regulatory risk and accelerating your safe market access across Europe and the UK.

Applicable regulation

The directives and standards we work with

Each recommendation ties back to a specific directive, annex, or harmonised standard.

RegulationNumberScope
Machinery Directive2006/42/ECEU machinery and partly completed machinery
Low Voltage Directive (LVD)2014/35/EUElectrical equipment 50–1000 V AC / 75–1500 V DC
Electromagnetic Compatibility (EMC)2014/30/EUEquipment that generates or is affected by EM disturbance
Radio Equipment Directive (RED)2014/53/EUProducts with radio transmission functionality
UKCA Marking FrameworkUK SI 2019/696General UKCA marking requirements
Supply of Machinery (Safety) RegulationsSI 2008/1597UK machinery safety regulation
Electrical Equipment (Safety) RegulationsSI 2016/1101UK electrical safety regulation
Electromagnetic Compatibility RegulationsSI 2016/1091UK EMC regulation
Next step

Get a realistic timeline for your ce / ukca marking project

In this 20-minute call, you will receive a list of applicable directives, likely testing needs, and clear next steps.