"Do you have a CE certificate?" is the most common and most misunderstood question put to a CNC subcontractor. The answer is: a machined part does not receive a CE mark; CE is the declaration of the manufacturer placing the completed machine or product in scope on the market. But this does not mean the subcontractor is outside the CE process; the technical file relies on documents coming from the supplier. Continuing our RoHS/REACH and quality assurance agreement articles, this article explains CE and the Machinery Regulation from the subcontracted part perspective.
What CE Is and Is Not
The CE mark shows that the manufacturer declares the product meets the essential health and safety requirements of the relevant EU harmonisation legislation (Machinery Regulation, Low Voltage, EMC, Pressure Equipment etc.). It is not a "certificate" but a declaration and mark made under the manufacturer's own responsibility; in most machine categories no third-party approval is required. Therefore the expression "CE certificate" is technically wrong; the correct terms are "EU Declaration of Conformity" and the technical file. ISO 9001 on the other hand is a quality management system certificate and has no direct connection with CE; the two are often confused.
From the Machinery Directive to the Machinery Regulation
Machinery Directive 2006/42/EC is being replaced by Machinery Regulation (EU) 2023/1230 from 20 January 2027. The Regulation applies directly (no transposition into national law is needed), allows digital instructions and a digital declaration of conformity, addresses machinery involving cybersecurity and artificial intelligence, makes third-party assessment mandatory for certain high-risk machine categories (Annex I Part A) and defines the concept of "substantial modification". From the subcontracted part perspective the basic concepts do not change: the distinction between machinery, partly completed machinery, safety component and component is retained.
Which Category Is a Subcontracted Part In?
| Concept | Definition (summary) | Example | CE / documentation obligation |
|---|---|---|---|
| Component | Part fitted to the machine with no function on its own | Machined shaft, flange, housing, bushing, bracket | No CE; supporting documents for the technical file (material, inspection) |
| Safety component | Component serving a safety function, placed on the market separately, whose failure endangers safety (Annex II list) | Emergency stop device, guard interlock, two-hand control | CE mandatory (by the component's own manufacturer) |
| Partly completed machinery | Assembly that is almost machinery but cannot perform a specific application on its own | Drive system, robot arm (without controller), sub-assembly | No CE; Declaration of Incorporation + assembly instructions |
| Machinery | Assembly fitted with a drive system, with parts joined for a specific application | Completed machine tool, conveyor, press | CE mandatory (manufacturer) |
Almost all machined CNC parts are in the "component" category. The subcontractor produces the part to the buyer's drawing; design responsibility lies with the buyer. Therefore the supplier cannot and should not make a CE declaration; doing so would be legally meaningless and misleading. Exception: if the supplier delivers an assembled sub-group and this group falls under the definition of "partly completed machinery", a Declaration of Incorporation may come into play; this scenario is covered in our sub-assembly supply article. A supplier selling a standard product of its own design (for example a coupling) is responsible for that product under the relevant legislation.
What to Request from the Supplier for the Technical File
The machine manufacturer must prove the properties of critical components in the technical file. What is requested in practice for subcontracted parts:
- Material certificate (EN 10204 3.1): For load-bearing parts, parts under pressure or contributing to a safety function. Our 3.1 article gives details.
- Inspection report / conformity report: Conformity of the part to the drawing; critical dimensions.
- Heat treatment and coating documents: Hardness report, coating thickness.
- Traceability: Lot/batch number, production date; required in case of recall.
- Certificate of Conformity (CoC): The supplier's declaration "produced according to order and drawing"; this is not a CE declaration and should not be called one.
- RoHS/REACH declaration: If the machine is in scope of electrical equipment.
- Change notification: Commitment to prior notification of changes in material, process or sub-supplier; to keep the technical file current.
The Supplier Machining Safety Components
If a buyer subcontracts the machined metal parts of a guard interlock or brake mechanism, these parts are still "components"; the safety component CE belongs to the manufacturer completing the interlock and placing it on the market. However, the buyer may define these parts as "safety-related" and request stricter control (100% inspection, special traceability, change prohibition); this expectation must be written clearly in the QAA and on the drawing. The supplier must know which parts are safety-related and keep its records accordingly (record retention period 10 years under the new Regulation).
Pressure Equipment and Other Legislation
Similar logic applies in other directives. Subcontracted machining of a valve body in scope of the Pressure Equipment Directive (PED 2014/68/EU) does not transfer the PED responsibility for the body to the machinist; however, the material certificate (sometimes 3.2 instead of 3.1), traceability and certain production controls are requested by the PED manufacturer. Under the Medical Device Regulation (MDR), too, subcontracted machining is defined as a "critical supplier" and is subject to buyer audits; CE responsibility again lies with the device manufacturer.
What Must Be Written in the Contract
- That design responsibility lies with the buyer; that the supplier is responsible for production to drawing.
- Which parts are safety-related / subject to the technical file and the document scope for them.
- Record retention period (10 years for machinery).
- Change management: notification of changes in material, process, sub-supplier.
- Recall and traceability cooperation.
- Use of correct document names (3.1, CoC, inspection report) instead of meaningless requests such as "CE certificate".
From the Turkish Supplier's Perspective
Turkey has largely harmonised EU technical legislation (the Machinery Safety Regulation is the counterpart of 2006/42/EC); Turkish machine builders know the CE process and subcontract shops are used to providing technical file supporting documents. When the buyer writes the documentation expectation clearly in the RFQ, the Turkish supplier includes it in the price; documents requested afterwards cause delays. Our standard document set is in our quality assurance article.
Frequently Asked Questions
Can I get a CE certificate for a subcontracted machined part?
No; a machined part of component nature is not in scope of CE. Request a material certificate, inspection report and Certificate of Conformity (CoC) from the supplier; you make the CE declaration as the machine manufacturer.
Does an ISO 9001 certificate replace CE?
No; ISO 9001 is a quality management system certificate, not a product conformity declaration. The two serve different purposes.
What does a supplier delivering an assembled sub-group declare?
If the sub-group is "partly completed machinery", a Declaration of Incorporation and assembly instructions; if not, only a Certificate of Conformity and supporting documents. Classification should be done together with the buyer.
How does the new Machinery Regulation affect the subcontractor?
It imposes no direct obligation; but machine manufacturers will require longer record retention, digital documents and change control. The supplier should be ready for these expectations.
Conclusion
CE is the responsibility of the manufacturer placing the machine on the market; the subcontracted CNC part manufacturer provides the correct documents feeding the technical file and notifies changes. Clarifying these boundaries in the contract removes both unnecessary "CE certificate" requests and the risk of missing documents. To receive a quote with a scope including technical file supporting documents (3.1, inspection report, CoC, traceability), send your drawings via our quote form.
