Machinery Safety
& CE/UKCA
Compliance Support

Specialist engineering expertise. Clearly defined deliverables. Support that fits your machinery project.

From ISO 12100 risk assessments and functional safety to technical documentation and conformity close-out, Orange-Tech provides the expertise to support and simplify machinery conformity assessment and CE or UKCA marking, as applicable.

Close-up photograph of an industrial robot arm and pneumatic gripper

A DEFINED STARTING POINT

ISO 12100 Machinery
Risk Assessments

From £1,950 + VAT

Documented hazards, risk-reduction measures and clear engineering actions.

Starting price subject to machinery complexity, available information and agreed scope.
Discuss your machine ↗

Six specialist work packages.
One coordinated compliance framework.

Machinery compliance requires more than a risk assessment. Our structured approach connects applicable requirements, risk reduction, functional safety, electrical compliance and EHSR evidence into a coordinated body of technical documentation.

Five technical assessment workstreams Expand to explore scope & deliverables

Applicable Requirements ReviewExplore package TECHNICAL RECORDRequirements and standards register

Establish the compliance basis before design decisions become expensive.

What we assess

Applicable legislation and standards, machine boundaries, intended use, destination market and conformity route.

What you receive

An applicable requirements and standards register, with a documented compliance basis.

ISO 12100 Risk AssessmentExplore package TECHNICAL RECORDRisk assessment and risk-reduction actions

Turn hazards into traceable engineering actions.

What we assess

Hazards across the lifecycle, risk estimation and evaluation, required risk reduction and residual risks.

What you receive

A controlled machinery risk assessment linking hazard scenarios, measures and outstanding actions.

Functional Safety AssessmentExplore package TECHNICAL RECORDSafety-function and verification records

Define what each safety function must achieve—and the evidence it needs.

What we assess

Safety-function identification, required performance levels (PLr), control architecture and relevant ISO 13849 verification evidence.

What you receive

A safety-function register, PLr assessment and verification register.

Electrical Compliance ReviewExplore package TECHNICAL RECORDElectrical compliance findings

Identify electrical safety gaps while corrective work can still be planned.

What we assess

Relevant electrical safety requirements, including EN 60204-1 where applicable, and the available design and test evidence.

What you receive

A documented electrical compliance review with findings and required corrective actions.

EHSR AssessmentExplore package TECHNICAL RECORDEHSR evidence matrix

Make the link between legal requirements and engineering evidence visible.

What we assess

Applicable Essential Health and Safety Requirements, their implementation and supporting evidence.

What you receive

An EHSR compliance matrix with evidence references and outstanding actions.

Each workstream can also be commissioned independently.

TECHNICAL FILE / EVIDENCE REVIEW

Technical File &
Conformity Close-Out

Explore package

What we assess

Technical-file completeness, evidence availability, action closure and conformity readiness.

What you receive

A structured technical-file review and final conformity-readiness status.

Consolidated evidence review, outstanding actions and conformity-readiness assessment.

Evidence completenessOutstanding actionsConformity readiness

Manufacturer & supplier inputs

Relevant design information, drawings, instructions, test evidence and other applicable records also contribute to the technical file.

Individual assessment or the complete work package.

START WITH A DEFINED NEED

Individual Assessments & Reviews

Commission the specific assessment or review your project needs.

Risk assessments from £1,950 + VAT

Subject to complexity, information and agreed scope.

FOR COMPLEX APPLICATIONS

Bespoke Compliance Projects

Tailored support for robotic cells, integrated systems, unusual applications and complex machinery.

Scoped around your project

BEFORE YOU COMMISSION

Machinery conformity
questions.

The right scope starts with the machine, the market and the evidence already available. Where findings require design changes, our automation engineering support can help resolve them.

What is required to CE or UKCA mark a bespoke machine?

Start with the destination market, supply date, machine classification and applicable legislation. Establish the relevant requirements, assess and reduce risks, assemble technical evidence and instructions, complete the applicable conformity assessment procedure and issue the appropriate declaration and marking. Bespoke manufacture is not a general exemption. Some machinery categories require particular assessment routes; third-party certification is not universally mandatory.

Which marking applies in GB, Northern Ireland and the EU?

Great Britain currently accepts CE or UKCA marking for machinery through the applicable route. Northern Ireland uses CE; CE plus UKNI applies where a UK body undertakes mandatory third-party assessment. UKCA alone is not valid for NI or the EU, and CE plus UKNI does not provide access to the EU market. EU machinery uses CE. The EU Machinery Regulation (EU) 2023/1230 becomes generally applicable on 20 January 2027; plan the compliance basis around the market and placing-on-market or putting-into-service date. GOV.UK marking guidance · European Commission machinery guidance.

Does every machine require a machinery risk assessment?

For machinery within the scope of the applicable supply legislation, the manufacturer must ensure a risk assessment is carried out and use it to inform design and construction. ISO 12100 provides a structured methodology. An assessment for new machinery and an employer’s assessment of work equipment serve different duties; the scope should make clear which is being addressed.

What normally belongs in a technical file?

A description of the machine, drawings and control-circuit information, the risk assessment, applicable requirements and standards, calculations and test reports, instructions, relevant supplier declarations and the machinery declaration. The detail depends on the machinery and legislation. A folder of component certificates alone does not demonstrate the safety of the assembled system.

Can Orange-Tech complete just the risk assessment?

Yes. Individual assessments and reviews can be commissioned separately. We agree the machine boundary, available information, access, outputs and exclusions before starting. If the assessment identifies a need for functional safety work or other evidence, that additional scope is discussed with you.

Can you review a machine that is already built?

Yes. A review can identify gaps in the existing design and evidence and organise the corrective actions. Physical changes or further testing may be necessary. For installed or modified equipment, we first distinguish machinery-supply obligations from workplace duties, including PUWER where applicable; an existing machine does not automatically need retrospective CE marking.

Who is responsible for the final Declaration of Conformity?

The manufacturer or other legally responsible party retains its applicable duties. Orange-Tech supports the engineering assessment and evidence; engaging a consultant does not transfer those duties or turn a consultancy review into certification. Responsibility for signing the declaration and the applicable assessment route is established at the outset.

When should machinery compliance work begin?

At concept and requirements definition, before the layout, guarding and control architecture are fixed. Early assessment allows risk reduction to influence design. Reviews should follow significant design changes and continue through verification, validation and handover. Late-stage support is possible, but outstanding design decisions still need to be resolved.

How are robotic cells and integrated systems assessed?

The assessment considers the combined application: robot, tooling, workpiece, fixtures, transfers, safeguarding and operating modes. Interfaces can introduce hazards absent from the individual machines. Supplier declarations are useful inputs, but the integrator must address system-level risks, access and restart arrangements, and the performance of the complete safety functions.

What information do you need for a quotation?

A short description of the machine, intended use, destination market, current stage, delivery timing and the support required. Tell us what drawings, risk assessments and test records already exist. No confidential designs or document uploads are needed for the initial enquiry; arrangements for detailed information can follow.

How long does a typical engagement take?

Timing depends on complexity, the quality of available information, site access, design maturity and the reviews required. We confirm the proposed programme after scoping the work. Corrective engineering and missing evidence can affect close-out, so the assessment schedule and the manufacturer’s completion activities are considered separately.

LET’S DEFINE THE WORK

Let’s discuss your engineering challenge.

Tell us about your project, where it stands and the support you need. We’ll discuss the scope and the next steps with you.

[email protected]

A useful first enquiry

Include your name, company and business email, along with:

  • The equipment, workflow or project involved
  • The challenge and the support you need
  • Your current project stage and timescale
Discuss Your Project

A brief outline is enough. Please leave confidential details out of your initial enquiry.

Photography: “KUKA 02” by Алексей Четверухин, CC BY 4.0. Resized, compressed and cropped for layout. Contextual image; no affiliation or endorsement implied.