These notes provide general orientation. A specific product requires assessment against its own facts and applicable requirements.
CE & UKCA fundamentals
What does CE marking mean?
The manufacturer uses CE marking to declare that the product meets the applicable EU requirements. For machinery, this includes the applicable essential health and safety requirements (EHSRs). The mark must be supported by the required conformity assessment, technical documentation and declaration. It is not a voluntary quality label or, in general, an approval issued by an authority.
Is CE a certification?
For many products, the manufacturer assesses conformity and makes the declaration. Some products and procedures require a notified body. The essential question is whether the correct process and evidence exist, not simply whether a certificate is available.
What is UKCA?
UKCA means UK Conformity Assessed and is a product marking used in Great Britain. EU, Great Britain and Northern Ireland need separate consideration. CE recognition remains available for a range of products in Great Britain, subject to the applicable product rules; the appropriate route must be checked.
How do placing on the market and putting into service differ?
In EU product legislation, placing on the market means the first making available of an individual product in the relevant market. Making available covers subsequent commercial supply too. Putting into service concerns first use for the intended purpose. Technical commissioning is not automatically the same legal event.
What is conformity assessment?
It is the process of demonstrating that a product meets the applicable requirements. It connects classification, legislation and standards, risk assessment, tests and evidence, technical documentation and the declaration. It is more than completing a form.
What is a declaration of conformity?
The formal title follows the applicable legislation: EC declaration of conformity under the Machinery Directive 2006/42/EC; EU declaration of conformity under the Machinery Regulation (EU) 2023/1230; and UK Declaration of Conformity for the UKCA route. The declaration must identify the product and responsible manufacturer and agree with the supporting technical documentation.
What is a declaration of incorporation?
For partly completed machinery, the Machinery Directive uses declaration of incorporation; the Machinery Regulation uses EU declaration of incorporation. Neither establishes conformity of the completed machine or entire installation. Assembly instructions, integration conditions, interfaces and responsibility for the final machinery must still be addressed.
Documentation & risk assessment
What belongs in technical documentation?
Technical documentation is the general term used here. The Machinery Directive distinguishes the technical file for machinery (Annex VII, Part A) from relevant technical documentation for partly completed machinery (Part B). The Machinery Regulation uses technical documentation (Annex IV). Its contents depend on the product and legislation, and may include drawings, risk assessments, calculations, test reports, instructions and declarations.
What is a risk assessment?
A systematic process to define the machine limits, identify hazards, estimate and evaluate risks. It provides the basis for risk reduction and is repeated as measures are developed. The documented results need to match the safety concept, technical documentation and instructions.
How do risk analysis and risk assessment differ?
Risk analysis is part of risk assessment and includes defining limits, identifying hazards and estimating risk. Risk assessment also includes risk evaluation. Risk reduction uses these results to select measures and reassess remaining risk.
What are residual risks?
Residual risks remain after protective measures have been applied. They must be assessed and communicated appropriately, for example in instructions and warnings. A warning does not by itself justify omitting a feasible technical protective measure.
What is a standards list?
It records the standards considered or applied to a product. A useful list includes editions, scope and links to the relevant evidence. Superseded standards and changes need assessment in relation to the actual product.
What does a documentation review check?
Completeness, plausibility and consistency across the agreed documents. Typical items include the declaration, instructions, risk assessment, standards list, test reports, supplier documents and marking information. Findings become a gap list and action plan.
Machinery safety, integration & retrofit
What is functional safety?
Functional safety concerns safety functions implemented through sensing, logic and actuation. Guard monitoring, emergency-stop functions and safe stopping are examples. Functions must be clearly specified, linked to risk reduction and supported by the required verification and validation evidence.
What is a safety concept?
A coordinated description of how risks will be reduced through the design, safeguards, operating modes, access arrangements and information for use. It connects the risk assessment with practical implementation and documents the interfaces between responsible parties.
What is an assembly of machinery?
Several machines or partly completed machines may form an assembly when arranged and controlled to function as an integrated whole. The actual functional and safety-related interdependence and the interfaces must be assessed. Individual CE marks do not settle the conformity of the whole installation.
What is functional interdependence within the production process?
This describes how machines depend on one another to achieve a common production result. Material flow, coordinated operations, process dependencies and common or overarching controls help determine the nature of the arrangement. Safety-related interdependence must also be examined.
What is safety-related interdependence?
This describes how hazards or protective measures extend across machine boundaries. Examples include transfer points, shared protection zones and safety-related control functions affecting several machines.
How can retrofit affect CE conformity?
Modernisation can change hazards, controls, protective measures or operating modes. The changed condition must be assessed and the documentation updated as needed. Not every modification automatically requires new CE marking.
What is a substantial modification?
Substantial modification is a defined term in Article 3(16) of the Machinery Regulation. Its criteria concern physical or digital changes and specified safety consequences; identifying a new hazard alone does not establish that the definition is met. Under the Machinery Directive, modifications must be assessed within the applicable framework. The Regulation’s definition should not be applied retrospectively as if it were already the Directive’s definition.
Import, distribution & market access
What should an importer check?
The relevant duties depend on the product legislation. Manufacturer identity, marking, declarations, instructions and the availability and plausibility of technical evidence are typical checks. An importer should establish its role before placing the product on the market.
What changes with a private-label product?
Placing a product on the market under your own name or trade mark can make you responsible as the manufacturer. Supplier records, declarations, marking and technical documentation need assessment against that role.
What does an EU authorised representative do?
The representative performs specified tasks under a written mandate within the applicable product rules. Scope, documentation access, retention, communication and responsibilities must be clear. The mandate does not remove the manufacturer’s own obligations.
Is an EU or UK address enough?
No. The role behind the address must be clear, with the appropriate mandate, access to evidence and arrangements for handling enquiries. EU and UK representative arrangements are distinct.
What documentation should a supplier provide?
The required scope depends on the product and its supply status. Relevant declarations, instructions for use or assembly instructions, integration conditions, safety information and agreed technical evidence should provide a reliable basis for the customer’s own work.
Methods & project work
What is House of Conformity?
A method developed by juristech to represent an installation, its machines and components, conformity status and functional and safety-related interdependence graphically. It highlights missing evidence and supports coordination between the integrator, suppliers and company operating the machinery.
Which training fits which team?
Design teams may need risk assessment and safety concepts; purchasing and import teams may need supplier checks and economic-operator duties; technical writers may need documentation structures and residual-risk information. Training is adapted to the participants and products.
How should a CE or UKCA project start?
Establish the product, target market, economic-operator role, project stage and available evidence. A structured review then shows what can be retained, what is missing and which actions should take priority.
Official terminology and guidance
Document names and definitions depend on the applicable legislation. The following sources support the distinctions used in this compendium.
Machinery Directive 2006/42/EC: Annexes II and VII
Machinery Regulation (EU) 2023/1230: Article 3 and Annexes IV and V
ISO 12100: risk assessment and risk reduction
GOV.UK: Supply of Machinery (Safety) Regulations 2008 — Great Britain