CE-marking your product (or not to)
What is CE-marking?
The letters 'CE' appear on many products in the EU.
CE stands for the French 'Conformité Européenne', which translates to 'European Compliance'. Manufacturers of products with the CE-marking declare that the products meet high safety, health and environmental protection requirements in response to EU legislation.
There biggest advantages to an CE-marking are:
- Businesses know that products bearing the CE marking can be freely traded in the EEA1 and Turkey;
- Consumers in the EEA and Turkey enjoy the same level of health, safety, and environmental protection.
The CE-marking is a clear indicator of a product's
compliance with EU legislation. It is thus not an indication the product was produced in the EEA or Turkey, it indicates the products was constructed in conformance with EU-legislation.
Placement of the CE-marking enables to product to move freely within the EEA and Turkey's market.
New Legislative Framework
Regulation 765/2008 lays down the definition, the format and the general principles governing the CE- marking. Decision 768/2008 provides for conformity assessment procedures that lead to its affixing.
The manufacturer is the entity ultimately responsible for the conformity of the product EU harmonisation legislation and for the affixing of the CE-marking. The manufacturer may appoint an authorised representative to affix the CE marking on his behalf.
Technical documentation
Prior to CE-marking the product, EU harmonisation legislation obliges the manufacturer to draw up technical documentation, containing information that demonstrates that the product conforms to the applicable requirements. This technical documentation must be available when the product is placed on the market, regardless where that is.
The technical documentation must be kept for 10 years, from the date placing the product on the market2. This is the responsibility of the manufacturer or the authorised representative established within the Union.
The contents of the technical documentation are laid down, in each Union harmonisation act, in accordance with the products concerned.
Technical requirements of the CE-marking
The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and/ or to the accompanying documents. The requirement for visibility means that the CE marking must be easily accessible for all parties. A minimum height of 5 mm is required to ensure that it is legible3 4. If the CE- marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. The CE-marking can have different forms (e.g. colour, solid/hollow) as long as it remains visible, legible and respects its proportions.
CE-marking accompanied by the number of a Notified Body
Where a Notified Body is involved in the assessment according to the applicable EU-legislation, its identification number must follow the CE-marking. Depending on the product, there may be more than one Notified Body involved. In that case, the numbers of all Notified Bodies must follow the CE-marking.
When (not) to CE-mark you product
The CE-marking must be affixed to the product before it is placed on the market. Where products are subject to several EU-harmonisation acts, which provide for the affixing of the CE marking, the CE-mark indicates that the products are declared to conform to the provisions all of these acts. In appendix 1 is an overview of product groups that require CE-marking.
In some cases a product is finished, CE-marked and placed on the market and then incorporated into a new product. In such cases it is possible for a product to have more than one CE-marking.
The CE-marking may NOT be placed unless there is a legislative ground for placing the mark.
Union harmonisation legislation providing in general for CE-marking may nonetheless exclude the application of the CE marking on certain products, for example partly completed machinery (Machinery Directive).
Sanctions
Member States must provide in their national legislation for appropriate measures to prevent the abuse and misuse of CE-marking, and to redress the situation if such abuse or misuse takes place. These may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.
Appendix 1 - Product groups with obligation of CE-marking5
• Active implantable medical devices (Directive 90/385/EEC)
• Appliances burning gaseous fuels (Regulation (EU) 2016/426)
• Cableway installations designed to carry persons (Regulation (EU) 2016/424)
• Construction products (Regulation (EU) No 305/2011)
• Eco-design of energy related products (Directive 2009/125/EC)
• Electromagnetic compatibility (EMC Directive 2014/30/EU)
• Equipment for use potentially explosive atmospheres (ATEX Directive 2014/34/EU)
• Explosives for civil use (Directive 2014/28/EU)
• Hot-water boilers (Directive 92/42/EEC )
• In vitro diagnostic medical devices (Directive 98/79/EC and Regulation (EU) 2017/746)
• Lifts (Directive 2014/33/EU)
• Low voltage (Directive 2014/35/EU)
• Machinery (Directive 2006/42/EC)
• Measuring instruments (Directive 2014/32/EU)
• Medical devices (Directive 93/42/EEC and Regulation (EU) 2017/745)
• Noise emission in the environment (Directive 2000/14/EC)
• Non-automatic weighing instruments (Directive 2014/31/EU)
• Personal Protective Equipment (Regulation (EU) 2016/425)
• Pressure equipment (Directive 2014/68/EU)
• Pyrotechnics (Directive 2013/29/EU)
• Radio equipment (Directive 2014/53/EU)
• Recreational craft (Directive 2013/53/EU)
• Restriction of Hazardous Substances (RoHS Directive 2011/65/EU)
• Safety of toys (Directive 2009/48/EC)
• Simple pressure vessels (Directive 2014/29/EU)
1 The European Economic Area (EEA) unites the EU Member States and the three EEA EFTA States (Iceland, Liechtenstein, and Norway) into an Internal Market governed by the same basic rules. These rules aim to enable goods, services, capital, and persons to move freely about the EEA in an open and competitive environment, a concept referred to as the four freedoms.
2 Unless there is an exception applicable; according to the Directives relating to medical devices and invitro diagnostic medical devices, these documents must be kept for 5 years and in the case of implantable medical devices for 15 year.
3 There are however exceptions are made for products such as machinery, PPE, active implantable medical devices, medical devices, potentially explosives atmospheres, lifts (safety components), IVD-medical devices, radio and telecommunications terminal equipment or marine equipment.
4 Furthermore there are exceptions made in case CE marking to the product is impossible. In such cases, the CE marking can be affixed to the packaging, and/or to an accompanying document.
5 Source: http://ec.europa.eu/growth/single-market/ce-marking/manufacturers/, 2 May 2019.
