The CE mark is not a quality award or a single certificate. It is the manufacturer's declaration that the product meets the requirements of all relevant EU legislation that applies to it. The first question should therefore not be "how do I get the CE certificate" but "which legislation does my product fall under".
A product can fall under several pieces of legislation
An electric hand tool can simultaneously fall under the Machinery Directive, the Low Voltage Directive, the EMC Directive and RoHS; if it has a wireless connection, the Radio Equipment Directive is added. The declaration covers all of them together; omitting one invalidates the whole declaration.
Frequently encountered legislation
| Regulation | Scope |
|---|---|
| 2006/42/EC Machinery Directive | Machines with moving parts and safety components |
| 2014/35/EU Low Voltage (LVD) | Electrical equipment operating within certain voltage ranges |
| 2014/30/EU EMC | Equipment that emits electromagnetic interference or is affected by it |
| 2014/53/EU Radio Equipment (RED) | Products containing a radio transmitter or receiver |
| 2011/65/EU RoHS | Restriction of hazardous substances in electrical and electronic equipment |
| EU 2017/745 Medical Devices (MDR) | Medical devices and their accessories |
| EU 305/2011 Construction Products (CPR) | Materials permanently incorporated into works |
| EU 2016/425 Personal Protective Equipment | PPE products |
| EU 2016/426 Gas Appliances | Gas-burning appliances and equipment |
| 2014/68/EU Pressure Equipment (PED) | Equipment operating above a certain pressure |
Is a notified body always required?
No. Each piece of legislation defines different conformity assessment modules according to the product's risk class. Under some modules the manufacturer can declare on the basis of its own control (self-declaration); under others, examination by a notified body is mandatory. Which module applies is determined by the annexes of the legislation.
A test report alone does not demonstrate CE conformity. Conformity is established by the whole of the technical file, the risk assessment, the harmonised standards applied, the conformity assessment module and the EU declaration of conformity.
The role of the harmonised standard
The legislation writes the essential health and safety requirements; harmonised standards make concrete how those requirements are to be met. Where a harmonised standard cited in the Official Journal of the EU is complied with, the relevant requirements are presumed to be met (presumption of conformity). Complying with the standard is not mandatory, but not complying leaves the manufacturer with the burden of proving that the requirement has been met by another route.
What does the technical file contain?
- Product description, drawings and circuit diagrams
- The list of legislation and standards applied
- Risk assessment
- Test reports and calculations
- The conformity assessment module and any notified body certificates
- The user manual and examples of the marking
- The EU declaration of conformity
Why is determining the scope the most expensive step?
The cost of mistakes made in the conformity process is not equal. If a test is done wrongly it is repeated; if a label is printed wrongly it is reprinted. But if the legislation applying to the product is determined incompletely, ALL SUBSEQUENT WORK is wasted: the technical file is built against the wrong essential requirements, testing is done to the wrong standards and the declaration refers to the wrong legislation. Scope determination is therefore done at the very start of the process and with the greatest care.
What makes determination difficult is that legislation is written by TYPE OF RISK rather than by type of product. The same product can fall under several pieces of legislation because it carries several risks: electric shock, electromagnetic interference, mechanical hazard, substance content, energy consumption. Each of these comes from a separate piece of legislation.
Four questions that determine the scope
- What is the product's INTENDED PURPOSE? The same device enters an entirely different regime when declared for a medical purpose; the statement of intended purpose is a technical decision, not marketing copy.
- To whom is the product sold? The sets of requirements diverge between professional users and consumers, and information and warning obligations change.
- What energy does the product run on and which interfaces does it have? The presence of a radio interface directly changes the applicable legislation.
- Is the product a whole, a component or an assembly? The obligations of a finished product and a component are not the same, and the party carrying out the assembly may move into the position of a new manufacturer.
Four common scope mistakes
| Mistake | Why it is wrong |
|---|---|
| Not assessing the finished product because the radio module is approved | Module approval is given for particular antenna and mounting conditions; because the enclosure, cabling and layout change, assessment on the finished product is required. |
| Skipping horizontal legislation | Substance restrictions, waste obligations and energy/ecodesign requirements create obligations independently of the marking; even where the marking is complete, placing on the market is unlawful unless these are met. |
| Treating component certificates as the finished product's certificate | Component certificates do not demonstrate the conformity of the finished product; the finished product carries its own technical file. |
| Applying the marking to a product outside the scope | This is a separate infringement independent of non-conformity; the justification "so that it shows quality" is not valid. |
How do you know whether a notified body is required?
The need for a body depends not on how complex the product is but on the conformity assessment MODULE prescribed by the legislation, and the module comes from the product's risk class. Under some legislation the body is not involved at all; under some it is involved without exception; under others it varies with the product's class or with whether the harmonised standard has been applied in full. That third case produces the most confusion: if the standards are applied in full the manufacturer can make its own declaration; if not, a body comes into play.
The output of scope determination should be a list: every piece of legislation applied, the module chosen for it, the harmonised standards to be used and any body that will be involved. That list is the first page of the technical file and, if it changes during the project, the justification is recorded.