So, you are intending to design and build a machine so you can sell it in the EU and GB market. What exactly must you do before you can legally place it on these markets?
The most important thing to understand is what legal status your machine has when it ships out of the factory. The timing matters too: as the new EU Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive on 20 January 2027, and there is no grace period.
What exactly are you building?
It is often thought that all you need to do is find a suitable test house and test against an array of standards. However, it’s important to recognize that manufacturers are obliged to demonstrate how they satisfy the legislation and not just a standard. The use of assessment and testing against test standards should be seen as part of the process and not the final goal.
Before considering or starting any testing, you should first consider three key aspects of your product:
- Is it a complete machine (M/C), or partly completed machinery (PCM) to be incorporated into something else?
- Is it on the high-risk list (Annex I), which may require a Notified Body?
- What other legislation applies alongside Machinery safety considerations (EMC, radio, pressure equipment, RoHS, CRA)?
In the lefthand column in the table below, there is a list of a few key requirements mandated by the Machinery Legislation. Under each of the other two columns, labelled M/C and PCM, you can see what is required in order to satisfy those requirements.
| | M/C | PCM |
| Declaration | Full compliance with all relevant legislation: Declaration of Conformity (DoC) | Does not meet all requirements on its own: Manufacturers must instead produce a Declaration of Incorporation (DoI). |
| Marking | CE marking (and/or UKCA) | No CE/UKCA marking for machinery safety |
| Instructions | Full instructions for use | Assembly instructions: safety measures to add, residual risks, how to integrate |
| Risk assessment and file | Whole machine | The part supplied |
| Use | Ready to use | Must be completed by the integrator, who becomes manufacturer of the finished machine. |
I should test to the standards, then I'm done, right?
No. Testing proves specific clauses are met. It doesn't prove the risk assessment is complete, that production units match the tested one, or that the instructions, marking and file are correct. A machine can pass every test and still be non-compliant.
Steps to CE marking
- Classify the product.
- Identify applicable legislation and standards. With the new Machinery Regulation, Harmonised standards are being reviewed. Most should carry over, some with restrictions, so check the current list.
- Carry out a risk assessment (EN ISO 12100).
- Manufacturers should design products to satisfy the EHSRs (Essential Health and Safety Requirements). The design philosophy for risks should be, ‘design-out’, where possible, mitigate through guarding, or as a final solution, use warning labels where it is not possible to remove all risk.
- Verify and validate: test, calculate, inspect. This can be through internal or external resources.
- Compile the technical file. A good Technical File should be a comprehensive collection of technical support documentation. It should include, but not be limited to: Product details/serial numbers/function description, GA Drawings, wiring diagrams, schematics, BOM, component approval certificates, installations/Operator instructions, test reports.
- Complete the conformity assessment: internal control for most machinery, notified body for Annex I where required.
- Issue the DoC, affix the marking, supply the instructions.
Affixing the name plate and CE marking should be seen as the final action. It is a legal claim that steps 1 to 7 were done, mandated by the Machinery Regulation. In conjunction with the accompanying DoC it forms part of the manufacturer’s statement that the product complies with all applicable legislation.
Core requirements
- Meet the EHSRs across the machine's whole life.
- A documented risk assessment, including foreseeable misuse.
- Instructions in the language of the country of use (digital allowed under the new Regulation, paper on request).
- Marking: manufacturer name and address, designation, year of construction.
- A DoC listing the manufacturer, product identification, standards applied, the person authorised to compile the file, and any notified body involvement.
- If you are outside the EU, decide who your authorised representative and importer are before you ship.
Who should be doing this?
The manufacturer has a responsibility to complete all the above and for someone within the organisation to finally sign the DoC. Someone within the organisation accepts responsibility and will be the point of contact for any approach from the surveillance authorities
What if I make more than one variant of a machine?
- Variants: define the machine family, assess a justified worst case, and cover clearly identified models in one declaration. If an option changes a hazard, it needs its own assessment.
- Reusing evidence: component certificates, identical subsystem reports and modular risk assessments can be shared across machines. Record why the evidence applies and keep it in one controlled place.
- Substantial modification makes the modifier the manufacturer, with full obligations. This covers your own retrofits and your customers' modifications.
Suggested next step:
At Technology International, we can help by working alongside your engineering and quality teams to classify products, review risk assessments and technical files, and prepare for the new Regulation, including pre-shipment checks and support for your customers' factory acceptance tests.
Compliance is cheapest when built in at design stage. A gap analysis of your product against current rules and the new Regulation shows what must change before it becomes a delivery problem.