“Do my products need CE marking?” Not a single day passes by that we do not get this question. In this post, we will try to give you some guidance on how you can answer this question yourself. If after you have read the post you still have questions, or need assistance, we will be glad to assist you.
Unfortunately, it can be difficult to determine if a product needs CE marking. Unfortunately, there is no authority that provides a product lists or nomenclature that names the products that require CE. Instead you will need to investigate this yourself. We recommend the following steps.
Step 1: Do you intend to sell in a country in which CE marking applies?
The CE marking applies to products placed in the market or put into service in the European Economic Area. Even so, it only it applies only for certain product groups or product aspects, as we will see in the next step. To answer the question whether a product needs to be CE marked, you first need to first check if the country or countries in which countries the products are going to be placed in the market or used are countries that require CE.
The CE marking is required only for certain products intended to be sold in the countries of the European Economic Area (EEA)
The CE marking is required in the countries that together form the European Economic Area (EEA):
- Austria (became member in 1995)
- Belgium (Founder Member in 1957)
- Bulgaria (2007)
- Croatia (2013)
- Cyprus (2004)
- Czech Republic (2004)
- Denmark (1973)
- Estonia (2004)
- Finland (1995)
- France (FM 1957)
- Germany (FM 1957)
- Greece (1981)
- Hungary (2004)
- Ireland (1973)
- Italy, (FM 1957)
- Latvia (2004)
- Lithuania (2004)
- Luxembourg (FM 1957)
- Malta (2004)
- The Netherlands (FM 1957)
- Poland (2004)
- Portugal (1986)
- Romania (2007)
- Slovakia (2004)
- Slovenia (2004)
- Spain (1986)
- Sweden (1995)
…as well as three members of the European Free Trade Association (EFTA):
* Iceland
* Norway
* Liechtenstein
Although Switzerland is member of the EFTA, it does not take part in the EEA.
PLEASE NOTE: Turkey is neither member of the EU, nor is considered a part of the EEA. However, Turkey has fully implemented many of the European CE marking directives. This means that for many products they also require CE Marking.
PLEASE NOTE ALSO: Now that the Brexit has been completed, and after a transition period, the United Kingdom will not longer require the CE marking, but they will require the UKCA conformity marking instead.
If the product is not intended to be made available in the aforementioned countries, it will not need CE marking.
The next step is to determine if the product is covered by one or more of the European CE marking directives or regulations.
Step 2: Is the product covered by the scope of a CE directive or regulation?
The CE marking is required only for products for which a CE marking directive or regulation has been adopted. There are directives/regulations for the following types of products (please note that one or more directive/regulation can apply to a single product):
- Toys (such as dolls, clay, lego etc), for example may be covered by:
- Machinery (such as packaging machines, metal presses, mixers, drills etc), for example may be covered by (among others):
- Electrical equipment (such as lighting, power adapters), for example may be covered by (among others):
- Electronic equipment (such as computers, tables, smartphones), for example may be covered by (among others):
- Personal protective equipment (such as helmets, gloves, boots, diving equipment, fall protection), for example may be covered by (among others):
- Pressure equipment, for example may be covered by (among others):
- Pressure Equipment Directive (2014/68/EU)
- Portable Pressure Equipment Directive
- Simple Pressure Vessels Directive
- Medical devices (such as heart monitors, diagnostic devices, therapeutic devices), for example may be covered by (among others):
- Medical Devices Directive (93/42/EC) / Medical Device Regulation (EU) 2017/745
- Active Implantable Medical Devices Directive
- In vitro diagnostica
- Gas appliances (such as for example cookers and heaters), for example may be covered by (among others):
- Lifts, for example may be covered by (among others):
- Recreational craft, for example may be covered by (among others):
- Equipment and protective systems for use in explosive atmospheres
- Non-automatic weighing instruments
- Cableways
- Construction products (such as doors, windows, cement) , for example may be covered by (among others):
- Explosives for civil use
- New hot water boilers
- Measuring Equipment
Are your product within the scope of one of these directives or regulations? If so, they require CE marking.
Products that do not require CE
The CE marking is NOT required for the following products:
- Chemicals
- Pharmaceuticals
- Cosmetics
- Foodstuffs
Products not covered by the European CE marking directives may still fall within the scope of other EU or national legislation. If no CE directive or regulation applies, the General Product Safety Directive (2001/95/EC) may apply. This General Product Safety Directives requires that products are safe, but is does not require any marking.
Need help?
At CEMARKING.NET, we have developed a Six Step CE Marking Framework that helps companies to do CE self-certification. We offer this Framework as an On-Line Workshop, as a Coaching Program, and as a Done-For-You service. The first step of this Framework is dedicated to determining which directives and standards apply to your products, and how you can do the CE marking efficiently and in a cost-effective way. We now offer this “Step 1” of our framework as a separate service. That means you can get a report with an overview of the applicable requirements and recommendations with the steps you need to take, without investing in the full service package. Contact us for more information on our services, click the Start Now-button.