The right standard. The right test. The right file.
Which standards apply to your machine? Many manufacturers cannot answer with certainty, and an incomplete list comes back at customs or during an inspection.
The right standards, measurable tests and a technical file you can defend. We build for you the documentation that answers the questions asked at customs or during an inspection.
- New regulation
- (EU) 2023/1230 — 20 January 2027
- Conformity route
- internal production control — self-declaration
- Test & report
- to the applicable EN standard
- Technical file
- kept for 10 years after the last unit
- Final step
- EU Declaration of Conformity — signature
The machinery rules are changing
Directive 2006/42/EC is being replaced by Machinery Regulation (EU) 2023/1230. The new text is a regulation, not a directive: it applies directly across the EU.
in force
published
ongoing
starts to apply
Digital documentation
Instructions and the declaration may be provided digitally; a paper copy is supplied free of charge if the buyer asks.
Software and AI
Software that determines safety functions, and cybersecurity, are now part of the risk assessment.
High-risk machinery list
The list replacing the old Annex IV has changed; for some products a notified body becomes mandatory.
“Substantial modification”
If a modification after placing on the market falls under this definition, the machine must undergo conformity assessment again.
Which legislation applies to your product?
A product can fall under more than one piece of legislation; the requirements of each must be met.
Machinery Directive
Any machine with moving parts
Low Voltage Directive
Electrical products rated 50–1000 V AC
EMC Directive
Devices that generate electromagnetic disturbance
Pressure Equipment Directive
Equipment with pressure above 0.5 bar
ATEX Directive
Equipment used in explosive atmospheres
Construction Products Regulation
Products permanently incorporated in construction works
Medical Device Regulation
Devices and accessories for medical purposes
RoHS Directive
Substance restrictions for electrical products
The process in four steps
Each step ends with something concrete in your hands. If you do not know which documents you need, the process starts here too.
Get in touch →- 01WhatsApp · e-mail
First contact
We look at your product and target market and clarify the scope.
You receiveScope note - 022–3 working days
Roadmap
We present a plan listing the legislation, tests and documents required.
You receivePlan and offer - 03throughout
Process management
We manage the technical file, tests and applications on your behalf.
You receiveTechnical file and test reports - 04follow-up included
Completion
The documents are completed; we follow validity and updates.
You receiveSigned EU Declaration of Conformity
Before and after production
The technical file is built in two phases. Tap a heading to see what is done at that step.
Completed before the product goes to market.
01Identifying the legislation
02Standards research
03Component certificates
04Risk assessment
Delivered with the product and kept on file.
05Instructions for use
06Test report
07Declaration of Conformity (DoC)
08Rating plate
One point of contact for your conformity documents
From product conformity to management systems, from testing to the declaration of conformity, you deal with one team.
CE Marking
Legislation mapping, technical file, test coordination and Declaration of Conformity.
Management Systems
Setup, internal audit and management of the certification process.
Testing
Coordination with accredited laboratories to the product-specific standards.
Export Certificates
EAC, GOST-R, Halal and other market-specific processes.
TAREKS & ÜTS
Import inspection in Turkey and product tracking system registrations.
Medical Devices & UDI
MDR/IVDR conformity, UDI-DI and ÜTS registration.
Sector Legislation
Toys, construction products, pressure equipment and more.
Standards
Scope, typical tests and the applicable legislation for each harmonised standard.
The process, step by step
From choosing the legislation to the technical file, from the test report to the signed declaration.
Find out which documents your product needs
Describe your product in one sentence. We will clarify the scope and the documents required.
