- Building inspection
- Fire alarms system testing
- Household appliances
- Installation materials
- Industrial machinery
- IT & audio video
- Laboratory, test & measurement
- Lighting equipment
- Maritime, oil & gas
- Medical & healthcare equipment
- Military & aerospace product testing
- Wireless & telecom
Nemko can help you solve the process of CE marking.
CE marking has existed in its present form since 1993. CE stands for “Conformité 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 marking 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
Download now: The CE process step-by-step guide for manufacturers
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 Nemko do?
Both as a test- and certification body and as a notified body Nemko can do the necessary work in order for you to do the required declaration and CE marking. Nemko 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, Nemko can issue the certificates required.
Want to learn more? Watch this short (5 min.) introduction video
Cyber security required for CE-marking
From August 2024, cyber security needs to be documented for products that need CE marking and are to be sold in Europe. This is a consequence of new requirements in the Radio Equipment Directive (RED).
In addition, a proposal for a new regulation was published in September 2022: The Cyber Resilience Act.
Watch this webinar to get an easy-to-understand update on the cyber security requirements in the Radio Equipment Directive and an introduction to the new EU Cyber Resilience Act as well
Watch the on-demand webinar now!