Skip to main content

FAQ's - The most often asked CE questions

1. What exactly is a CE marking?​

The CE marking establishes a minimum safety standard for technical products within the European internal market.

By affixing the CE marking, the manufacturer legally declares that their product is developed and manufactured in accordance with applicable EU directives and EU-wide harmonized standards. The CE marking is thus applied under the sole responsibility of the manufacturer or their authorized representative.

This also applies to equipment and machinery that are self-designed and manufactured. Here too, the manufacturer or operator is obliged to provide their employees with safe machinery and equipment for the production of their own products.

The harmonized regulations for the individual product groups are defined in the EU directives. These have been implemented into national law in each member state. In Germany, this is the ninth regulation of the Product Safety Act (ProdSG).

2. Why even have a CE mark?​

Unfortunately, many companies often only really begin to focus in depth on machine safety after following an safety related incident. Lifelong health consequences, up to and including death, can no longer be dismissed with "we've always done it this way."

Of course, proper machine safety is also associated with a certain amount of effort. However, with legally compliant, structured, and above all complete technical documentation, you can stand out from the crowd of your competitors. Many clients (especially large corporations or municipalities) place great value on flawless technical documentation from their suppliers.

3. What do I need for CE marking?​

Before you may affix the CE mark to your product or machine, you will need the following:

First, your machine must, of course, be safe. The minimum requirements for this are defined in the relevant standards.

In a risk assessment, all hazards posed by the machine and its operation must be analyzed and mitigated or, ideally, completely eliminated.

In addition, detailed operating instructions are required. These are essential for the safe operation of the machine and also includes information on maintenance, actions to take in case of malfunctions, and residual risks. The operating manual must be available to the operator at all times.

For all hazards that cannot be completely prevented, pictograms with mandatory, warning, and danger notices must be affixed to the machine.

Once these points have been fulfilled, the manufacturer issues the Declaration of Conformity or Declaration of Incorporation.

Now you may also affix the CE mark to your machine, usually on the nameplate.

4. ...and if we only use the machine internally?​

Even products, machines, systems, and equipment that you use internally must comply with the applicable standards and therefore require a CE mark.

Your manufacturer obligations are not dependent on whether you sell your equipment or machine to an end customer. The Machinery Directive requires you to ensure the safety of your machine "before placing it on the market and/or putting it into service."

5. What about old machines without a CE mark?​

Machines or systems that were first placed on the market before the Machinery Directive came into force do not have a CE mark on their nameplate.

If you purchase such a used machine without a CE mark, you are generally not required to undergo the conformity assessment procedure retrospectively.

However: If the old system has been "substantially modified" or integrated into an "assembly of machines," a new CE marking procedure must be carried out in any case.

But: It must still be ensured that old systems meet current safety standards! As an operator, you must ensure that your employees can operate the system safely. If this is not the case, you need to improve the safety features and protective measures.

6. What exactly is "placing on the market" and "putting into service"?​

"Placing on the market" according to the Machinery Directive is the "first-time availability of a machine [...] in the Community" (meaning the European Community, i.e., the European Economic Area). "Putting into service," on the other hand, refers to the "first-time intended use."

This distinction is important for CE marking because it defines who the manufacturer is. The manufacturer is legally responsible for machine safety. The manufacturer is the one who places the machine on the market under their name and brand.

It is not relevant whether the product is actually new, but only whether it is new to the European market!

For example, consider an importer of machines from so-called "third countries." If this importer wishes to sell machines in the European Economic Area, they are the one who wants to "place the machines on the market" in the Community and thus inevitably assumes manufacturer responsibilities under the Machinery Directive. Consequently, the importer is legally responsible for ensuring that their product meets European safety requirements.

7. What counts as a "substantial modification"?​

For many manufacturers or operators, the question arises about what happens to the CE marking if changes are made to a machine. The short answer is: CE conformity loses its validity if a "substantial modification" has been made.

If you have made a substantial modification to a machine, the result of this modification is legally considered a "new" machine. As a result, you become the manufacturer of this "new" machine, with all the associated responsibilities.

The Machinery Directive itself does not define "substantial modification." The Federal Ministry of Labour and Social Affairs has published the interpretative paper "Substantial Modification of Machines" on this topic.

With the help of this paper (especially the included flowchart), you can easily assess the situation.

If a machine is considered "substantially modified," it must undergo a new, separate assessment procedure with regard to CE conformity.

8. What is are "linked machines" or an "assembly of machinery"?​

A "linked machine" or "assembly of machines," as it is officially called, refers to the situation where multiple machines or machine parts fulfil a overall function and are "technologically or safety-wise" interconnected.

It is not sufficient to conduct risk assessments for the individual components. The combination of plant parts and all hazards that may arise from the interaction of the components must be considered.

This means that even if CE-compliant machine parts are combined, new hazards may arise at the interfaces, which must in turn be reassessed through a CE evaluation procedure for the entire system as a whole.

9. What is an "incomplete machine"?​

An incomplete machine is "an assembly that nearly constitutes a machine but does not perform a specific function on its own."

Simply put, this refers to all components that are installed in a larger machine or system.

A classic example is an electric motor: the motor by itself does not perform a function; it is only when used in conjunction with other components that it serves a purpose.

For an incomplete machine, a so-called "Declaration of Incorporation" is issued instead of a Declaration of Conformity. Instead of a traditional operating manual, an "assembly instruction" is created and attached to the product.

10. What is a "Declaration of Conformity" or "Declaration of Incorporation"?​

The Declaration of Conformity or Declaration of Incorporation (for incomplete machines) is the document in which the manufacturer declares that their product or system is developed and manufactured according to all applicable EU directives and harmonized EU standards.

This is a separate document that must be provided to the end customer or operator, along with the operating manual, no later than at delivery.

The declarations must include, among other things, the manufacturer's address, if applicable, the address of the documentation officer, a description of the machine, the applied directives and standards, as well as a signature by the manufacturer.

These documents are not certificates and are not reviewed and certified by an official body. They are issued by the manufacturer, who is responsible for the accuracy of the declaration.

11. Do operating manuals need to be translated?​

The answer according to the Machinery Directive is clear: Yes!

Operating manuals must be written in the official language(s) of the country where the machine is placed on the market or operated.

This means for you as a manufacturer: For each country where you want to sell or operate your machine, you must provide the operating manual to the operator in their official language.

12. How does it work if I want to sell products in the United Kingdom?​

Before Brexit

Products that were CE marked were allowed to be sold throughout the EU, including the UK.

After Brexit

UKCA Marking: Post-Brexit, the UK introduced its own mark called the UK Conformity Assessed (UKCA) mark. This mark is required for products sold in Great Britain (England, Scotland, and Wales). The UKCA mark is similar to the CE mark but is specific to the UK market.

Northern Ireland: For Northern Ireland, the CE mark is still accepted due to the Northern Ireland Protocol, which allows Northern Ireland to align with EU regulations in certain areas.

Transition Periods - UPDATED!

CE Marking Transition: There was initially a transition period allowing products with CE marking to be sold in the UK until the end of 2024. In a recent UK Government update, (https://www.gov.uk/guidance/ce-marking) this deadline has been extended indefinitely, meaning CE certified products may continue to be marketed and sold in the UK indefinitely unless they fall under one of the following categories.

  • Medical devices
  • Construction products
  • Marine equipment
  • Rail Products
  • Cableways
  • Transportable pressure equipment
  • Unmanned aircraft systems

Dual Marking: Some products might need both CE and UKCA markings to be sold in both markets, depending on the product and its specific regulations.

Key Steps to Sell Products in the UK

Determine Requirements: Identify if your product needs both CE and UKCA marking or just one. This depends on where you plan to sell (Northern Ireland vs. Great Britain) and the specific product regulations.

Compliance: Ensure your product meets all the relevant regulations and standards for both CE and UKCA marking, if applicable. This may involve testing, documentation, and sometimes certification by a notified body or conformity assessment body.

Marking: Apply the CE or UKCA mark to your product, as required. For UKCA marking, you must also include the UKCA mark on the product, packaging, or documentation as per the guidelines.

Documentation: Keep the necessary technical documentation and a Declaration of Conformity to support the compliance of your product with relevant regulations.

Contact Authorities: For any uncertainties, you may want to consult the relevant UK regulatory body or a compliance specialist to ensure that you meet all the necessary requirements for the market you are targeting.

Summary

In summary, the UK government has laid down legislation to continue recognition of current EU requirements, including the CE marking for a range of product regulations. This means businesses will have the flexibility to use either the UKCA (UK Conformity Assessed) or CE marking to sell products in Great Britain (GB).

Continued recognition of current EU requirements, including CE, will apply to 21 product regulations. This includes the 18 product regulations owned by the UK Department for Business and Trade (DBT). Following feedback from industry, recognition for a further 3 regulations, covering ecodesign, civil explosives and restriction of hazardous substances (in electrical equipment) have also been included.

The DBT regulations in scope of this UK legislation are:

  • Equipment for Use in Potentially Explosive Atmospheres Regulations 2016/1107
  • Electromagnetic Compatibility Regulations 2016/1091
  • Lifts Regulations 2016/1093
  • Electrical Equipment (Safety) Regulations 2016/1101
  • Pressure Equipment (Safety) Regulations 2016/1105
  • Pyrotechnic Articles (Safety) Regulations 2015/1553
  • Recreational Craft Regulations 2017/737
  • Radio Equipment Regulations 2017/1206
  • Simple Pressure Vessels (Safety) Regulations 2016/1092
  • Toys (Safety) Regulations 2011/1881
  • Aerosol Dispensers Regulations 2009/2824
  • Gas Appliances (EU Regulation) 2016/426
  • Supply of Machinery (Safety) Regulations 2008/1597
  • Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001/1701
  • Personal Protective Equipment (EU Regulation) 2016/425
  • Measuring Instruments Regulations 2016/1153
  • Non-automatic Weighing Instruments Regulations 2016/1152
  • Measuring Container Bottles (European Economic Community (EEC) Requirements) Regulations 1977
  • Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘the RoHS Regulations’)
  • Ecodesign for Energy-Related Products Regulations 2010
  • Explosives Regulations 2014

(V0.0.3)