15th December 2015 | By: jasonvicente
A Guide to CE Marking Products as a Manufacturer – Introduction
If you’re a manufacturer or a design company, there will likely come a time when you need to CE mark your products in order for them to be sold to businesses and consumers. “The CE marking is a key indicator (but not proof) of a product’s compliance with EU legislation”. Whilst there are exemptions (detailed below), the rule of thumb is that if the product is going to be sold, it needs to be CE marked. The exact definition is as follows:
Union harmonisation legislation applies when the product is placed on the market and to any subsequent operation which constitutes making it available until it reaches the end-user […] A product is made available on the market when supplied for distribution, consumption or use […] in the course of a commercial activity, whether in return for payment or free of charge.
A product is not considered to be made available when it is “transferred for testing or validating pre-production units considered still in the stage of manufacture” or “displayed or operated under controlled conditions at trade fairs, exhibitions or demonstrations”.
It’s important to note that the standard applies to new, finished products. However, taking an existing product that is CE marked, and modifying it, may require the process to be repeated, as it may then be considered a new product. The European guidelines state:
[…] if the risk assessment [of the modified product] leads to the conclusion that the nature of the hazard has changed or the level of risk has increased, then the modified product has to be treated as a new product i.e. compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the modification has to fulfil the same requirements as an original manufacturer, for example preparation of the technical documentation, drawing up a EU declaration of conformity and affixing the CE marking on the product. […] It is not necessary to repeat tests and produce new documentation in relation to aspects not impacted by the modification.
The definition of finished is also quite ambiguous. If you are retailing a sub assembly that has no use on its own and serves the sole purpose of being incorporated into a larger assembly, this may still require CE marking. The logic is that the products ‘end-use’ may in fact be the assembly or incorporation into a larger assembly and finished product. Please note that the fact that components or parts of a product are CE marked does not automatically guarantee that the finished product also complies with relevant standards.
It is not legal to make a product available for purchase within the European Union – be it via catalogues, websites etc. – if the product has not undergone CE marking. However, manufacturers may promote the product, on the proviso that it is not yet readily available for orders within the European Union.
If the product falls within any of the categories requiring CE marking, then it becomes a legal and mandatory requirement to undertake this process. Keep in mind that CE marking is a Europe-wide standard, and therefore once this has been undertaken it enables the product to be freely transferred within the European market.
There are several reasons why CE marking exists. Fundamentally, it comes down to the following 3 points:
- It shows that the manufacturer has checked that the product(s) meets EU safety, health or environmental requirements
- It serves as an indicator of a product’s compliance with EU legislation
- It allows the free movement of products within the European market
By placing the CE marking on a product a manufacturer is declaring, on their sole responsibility, conformity with all of the legal requirements to achieve CE marking. This is an important point which we will cover in more detail later, but fundamentally a large number of product categories can be ‘self certified’ by the manufacturer, without requiring a third party independent conformity assessment (usually by a notified body).
What this means is that CE marking can, in many cases, almost be seen as an internal due diligence process. It enables manufacturers (and design consultants) to sense check their product designs and processes, and provides a public assurance that this has been done in accordance with required standards.
If you are the manufacturer, you have a responsibility to fulfil a number of obligations (each of which will be covered in a subsequent post):
- Carry out a conformity assessment with the relevant directives (see below)
- Set up a technical file for the product being manufactured
- Issue an EC Declaration of Conformity
- Create and supply relevant product usage instructions and safety information, in a language easily understood by consumers and other end-users
- Satisfy traceability requirements, specifically:
- Keep the Technical File and EC Declaration of Conformity for a minimum of 10 years, or however long is specified in the relevant directive
- Ensure that the product carries a type, batch or serial number or other element allowing its identification
- Indicate the following three elements: manufacturer’s (1) name, (2) registered trade name or registered trade mark and (3) a single contact postal address on the product or when not possible because of the size or physical characteristics of the products, then on its packaging and/or on the accompanying documentation
- Place the CE mark on the product (or in some instances on the packaging)
For the avoidance of doubt, “the manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark”, meaning you are not exempt from these responsibilities simply because you are not physically manufacturing the product.
The first step that you’re probably wondering is ‘Does my product fall within one of the categories requiring CE marking’? Fortunately, this is also the easiest question to answer in the process. As a starting point, you may want to download this document and jump to page 13. Whereas this is a comprehensive document, it can be overwhelming and a difficult read if you don’t know what you’re looking for, or where to begin. This series of posts, written in response to popular demand on this topic, will aim to simplify this process substantially.
The product categories covered and requiring CE marking are as follows:
- active implantable medical devices
- appliances burning gaseous fuels
- cableway installations designed to carry persons
- eco-design of energy related products
- electromagnetic compatibility
- equipment and protective systems intended for use in potentially explosive atmospheres
- explosives for civil uses
- hot-water boilers
- household refrigerators and freezers
- in vitro diagnostic medical devices
- low voltage
- measuring instruments
- medical devices
- noise emission in the environment
- non-automatic weighing instruments
- personal protective equipment
- pressure equipment
- radio and telecommunications terminal equipment
- recreational craft
- safety of toys
- simple pressure vessels
Please note: chemicals, pharmaceuticals (including cosmetics) and food-related products do not fall under CE marking regulations.
Once you’ve looked through this list and you have some idea of whether or not your product is covered, or likely to fall under one of the listed categories, it’s time to identify the EU Directives that are relevant.
Let me explain this a bit further. Depending on the product (eg: a Vending Machine) it may fall under one or more directives. You must take in to account all the directives that apply in order to be compliant.
For each directive, there exists a set of Harmonised Standards, defined at the EU level, that set out the essential safety requirements in detailed technical terms. However, the use of these Harmonised Standards is voluntary – you have the choice to identify other ways of fulfilling the essential safety requirements. If you choose not to follow the safety requirements of a standard as it is written in the Harmonised Standards, you will then need to show that your product is equally safe, by presenting supporting documentation.
The main directives you need to be aware of are as follows (it’s probably a good idea to highlight or otherwise note the ones you think may apply to your product(s) as you read through them). I have highlighted in bold the ones we will cover in subsequent posts:
- RoHS – The restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU)
- Appliances burning gaseous fuels (Directive 2009/142/EC)
- Eco-design requirements for energy-related products (Directive 2009/125/EC)
- Simple pressure vessels (Directive 2009/105/EC)
- Toys’ safety (Directive 2009/48/EC)
- Electrical equipment designed for use within certain voltage limits (Directive 2006/95/EC)
- Machinery (Directive 2006/42/EC)
- Electromagnetic compatibility (Directive 2004/108/EC)
- Measuring instruments (Directive 2004/22/EC)
- Non-automatic weighing instruments (Directive 2009/23/EC)
- Cableway installations designed to carry persons (Directive 2000/9/EC)
- Radio equipment and telecommunications terminal equipment (Directive 1999/5/EC)
- Active implantable medical devices (Directive 90/385/EEC)
- Medical devices (Directive 93/42/EEC)
- In vitro diagnostic medical devices (Directive 98/79/EC)
- Pressure equipment (Directive 97/23/EC)
- Transportable Pressure equipment (Directive 2010/35/EU)
- Aerosol Dispensers (Directive 75/324/EEC as amended)
- Lifts (Directive 95/16/EC)
- Recreational craft (Directive 94/25/EC)
- Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 94/9/EC)
- Explosives for civil uses (Directive 93/15/EEC)
- Pyrotechnics (Directive 2013/29/EU)
- Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (Council Directive 92/42/EEC)
- Personal protective equipment (Directive 89/686/EEC)
- Marine equipment (Directive 96/98/EC)
- Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC)
- Emissions from non-road mobile machinery (Directive 97/68/EC as amended)
- Energy labelling (Directive 2010/30/EU)
When carrying out a risk assessment in consideration of one of the above directives, “manufacturers have to match a level of protection corresponding to the use they prescribe to the product under the conditions of use which can be reasonably foreseen”. This therefore excludes conditions of gross unintended use, and the hazards that may arise from it, but manufacturers must consider “conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour”.
Hopefully at this stage you understand what CE marking is, why it is necessary, and who it applies to. In the next post we’ll cover the general ‘essential requirements’, including how to identify risks and document these, before diving in to some of the directives in more detail.
References and additional reading: