Machinery Directive 2006/42/EC
Machines, safety components, partly completed machinery.
Machinery Regulation (EU) 2023/1230
Replaces the directive. Adds digital instructions, safety software and cyber-protection requirements, and defines “substantial modification”.
Applies 20 Jan 2027
Compliance · CE marking · Welding certification
CE marking and welding certification, engineered in.
A product is only finished when it can legally be sold in the EU. We build the evidence alongside the design — risk assessment, test rigs, test reports and the technical file — so you arrive at the notified body, the test lab or your own signature with nothing missing.
A
The route to CE marking
Six steps, the same for a test rig, a battery pack or a converted machine. The manufacturer signs; we make sure the signature rests on solid ground.
- 01
Classify
Identify every directive and regulation that applies — machinery, low voltage, EMC, radio, batteries, RoHS — and whether a notified body is required.
- 02
Essential requirements
List the essential health and safety requirements of each act and decide which harmonised standards give presumption of conformity.
- 03
Risk assessment
EN ISO 12100 risk assessment and risk reduction built into the design — not written after it. Safety functions sized to EN ISO 13849-1 (PL) or EN IEC 62061 (SIL).
- 04
Verify & test
Calculations, validation of safety functions, pre-compliance tests in-house and accredited testing where the standard or the buyer demands it.
- 05
Technical file
Drawings, schematics, risk assessment, test reports, standards list and instructions compiled into one traceable technical documentation package.
- 06
Declare & mark
The manufacturer signs the EU Declaration of Conformity and affixes the CE marking and rating plate. The file is kept for 10 years.
B
The technical file — we write it with you
The technical documentation is what market surveillance asks for and what a notified body reviews. We produce it as part of the engineering work, structured to Annex VII of the Machinery Directive (Annex IV of the new Regulation), Annex III of the LVD and the EMC and Radio directives.
- Gap analysis of an existing product or file
- Drawings, schematics and harness documentation to release standard
- Risk assessment, PL/SIL calculations and validation records
- Test plans, rigs and coordination with accredited labs
- Instructions, rating plates and EU Declaration of Conformity drafts
- AGeneral descriptionProduct, intended use and reasonably foreseeable misuse
- BDrawings & schematicsAssembly and part drawings, circuit diagrams, harness drawings, control logic
- CRisk assessmentHazard list, risk estimation, protective measures, residual risks
- DStandards appliedHarmonised standards and other technical specifications, clause by clause
- ECalculations & test reportsStrength, thermal, PL/SIL, EMC, electrical safety, battery and environmental tests
- FInstructionsUser and maintenance instructions in the language of the market — Swedish in Sweden
- GProduction controlMeasures that keep series units in conformity: routine tests, inspection plans, traceability
- HEU Declaration of ConformityOr Declaration of Incorporation for partly completed machinery
C
What the EU requires — for the products we build
Machines, battery systems, electronics, connected sensors and converted vehicles each fall under several acts at once. Several of them change in 2026–2027.
2024202520262027TodayBattery CE marking2023/1542GPSR applies2023/988RED cybersecurity2022/30Battery labels2023/1542CRA reporting2024/2847Machinery Regulation2023/1230Battery passport2023/1542CRA in full2024/2847
Low Voltage Directive 2014/35/EU
Electrical equipment at 50–1000 V AC or 75–1500 V DC.
EMC Directive 2014/30/EU
Electromagnetic emissions and immunity of apparatus and fixed installations.
RoHS 2011/65/EU · WEEE 2012/19/EU
Restricted substances in EEE, and take-back and marking at end of life.
Batteries Regulation (EU) 2023/1542
CE marking, safety, labelling, carbon footprint, recycled content and the digital battery passport for EV, LMT and industrial batteries above 2 kWh.
Labels Aug 2026 · Passport Feb 2027UN 38.3 · ADR
Transport tests every lithium cell and pack must pass before it can be shipped.
Radio Equipment Directive 2014/53/EU
Everything with a radio — LoRa, Bluetooth, Wi-Fi, LTE. Cybersecurity requirements via Delegated Regulation (EU) 2022/30 and EN 18031.
Cyber since Aug 2025Cyber Resilience Act (EU) 2024/2847
Security by design and vulnerability handling for products with digital elements.
Reporting Sep 2026 · Full Dec 2027
Type approval (EU) 2018/858 · 167/2013 · 168/2013
Cars and trucks, tractors, and L-category vehicles — with UNECE R100 for electric powertrain safety and R10 for EMC.
Recreational Craft Directive 2013/53/EU
Boats 2.5–24 m, including post-construction assessment after major conversions.
General Product Safety Regulation (EU) 2023/988
Safety net for consumer products not covered by a specific act.
Market Surveillance Regulation (EU) 2019/1020
Requires a responsible economic operator in the EU for CE-marked products.
REACH (EC) 1907/2006 · Ecodesign (EU) 2024/1781
Substances of very high concern, and the coming product sustainability requirements.
Converting or rebuilding a machine? A conversion to battery-electric can be asubstantial modification. Whoever makes it then takes on the manufacturer’s obligations — new risk assessment, new technical file, new declaration. We plan conversions with that in mind from day one.
D
Welding certification — EN 1090 and EN ISO 3834
Load-bearing steel and aluminium components sold in the EU need CE marking under the Construction Products Regulation (EU) 305/2011 — now being replaced in stages by (EU) 2024/3110 — through EN 1090-1. Machine builders, rail and pressure-equipment suppliers are asked for EN ISO 3834. Both rest on the same foundations.
- 01
Scope & class
Execution class EXC1–EXC4 per EN 1090-2 for structures, or quality level per EN ISO 3834 (-2 comprehensive, -3 standard, -4 elementary).
- 02
Welding coordination
A responsible welding coordinator with the right technical knowledge per EN ISO 14731 — we help define the role and the tasks.
- 03
WPS & WPQR
Welding procedure specifications per EN ISO 15609-1, qualified by procedure test to EN ISO 15614-1 or by the alternative routes in EN ISO 15610–15613.
- 04
Welder qualification
Welders tested to EN ISO 9606-1 (steel) or -2 (aluminium); welding operators and robots to EN ISO 14732.
- 05
Inspection & NDT
Visual inspection to EN ISO 17637, NDT by EN ISO 9712 certified personnel, acceptance to EN ISO 5817 / 10042 quality levels.
- 06
Certification
Factory production control audit by a notified body: EN 1090 certificate and CE marking of structural components, or EN ISO 3834 certificate.
E
Test rigs designed to the standard
A test is only as good as the fixture that holds the product. We design and build the rigs, fixtures and end-of-line stations that harmonised standards call for — so results are repeatable, accepted by the lab and reusable in series production.
Vibration & shock fixtures
Rigid, resonance-checked fixtures that carry cells, modules and packs on the shaker table in all three axes.
IP & IK test fixtures
Dust-chamber and immersion fixtures, spray-test mounts and impact-test holders for enclosures.
EMC test set-ups
Non-conductive supports, ground-plane layouts, cable routing and load simulators to the standard’s geometry — and pre-compliance benches before the lab.
End-of-line test stations
Protective-bonding continuity, insulation resistance and voltage withstand tests for every machine leaving the line.
Safety-function validation benches
Fault-injection rigs that prove an e-stop, interlock or speed monitor reaches its required performance level.
Battery abuse & safety rigs
Short-circuit, overcharge, crush and thermal-propagation test fixtures with containment and instrumentation.
Harness & crimp testers
Pull-out, continuity and hi-pot boards that test every harness the same way, in prototype and in series.
Welding test-piece jigs
Jigs that hold procedure and welder test coupons in position, gap and angle — and the sectioning plan for the specimens.
We are an engineering partner, not a notified body. Certificates are issued by notified and accredited bodies (in Sweden accredited through Swedac) — we make sure you arrive with everything they will ask for.
Next step
Not sure which rules apply to your product?
Send us a short description and a photo or drawing. We will tell you which directives and regulations apply, whether you need a notified body, and what is missing from your file.