CE marking has existed in its present form since 1993. CE stands for “Conformitée Européenne”, which in practice means that it “conforms to European directives”. CE marking of a product means that it complies with the legal requirements placed on the product within the EEA and therefore can be sold there. The manufacturer or their authorised representative gives the product its CE marking and is liable for ensuring that the product complies with the requirements of the directives. The primary purpose of CE marking is to facilitate free trade of goods within the EU. A secondary purpose is the harmonisation of laws concerning safety, health and the environment within the EU.
CE Marking is Mandatory
CE marking is mandatory for allowing access to the European Union. This is dictated by a number of directives and covers most products.
For electrical and electronic products the below 10 directives are the most commonly used:
- Low Voltage Directive (LVD) 2014/35/EU
- EMC Directive 2014/30/EU
- Radio Equipment Directive (RED) 2014/53/EU
- Restriction of the use of certain hazardous substances (RoHS), Directive 2011/65/EU
- Energy related Products Directive (ErP) 2009/125/EC
- Maritime Equipment Directive (MED) 2014/90/EU
- Equipment and protective systems intended for use in potentially explosive atmospheres (ATEX) 2014/34/EU
- Medical Device Regulation (MDR) 2017/745/EU
- Construction Products Regulation 305/2011/EU (CPR)
- Machinery Directive (MD) 2006/42/EC
CE marking– how to obtain it?
For most products, the CE marking is essentially based on the manufacturer’s own declaration of conformity with the relevant directives. If you are uncertain about which directives apply to your product, you may contact Nemko. We offer a CE pre-compliance service where the output is a report that defines the directives and standards your product falls under. The report will also include an overview of the required documentation you need to put together in a technical construction file for your product and a meeting with one of our experts to answer questions you have in connection with the CE marking of your product. In the case of some high-risk products, like medical products, the involvement of a Notified Body is required. This may also be the case when European product standards are not used.
What can UnCerts do?
Both as a test- and certification body and as a notified body UnCerts can do the necessary work in order for you to do the required declaration and CE marking. UnCerts can do the necessary product testing and build the technical file you need. for directives where a Notified Body is required to be involved, like for medical equipment, UnCerts can issue the certificates required.