Nemko can help you solve the process of CE marking.
Nemko having rich experience in European market access can do the necessary work for you to complete the required declaration and CE marking. We can do the necessary product testing and help you to prepare the technical file as per scheme requirements. For directives where a Notified Body is required to be involved, like for medical equipment, etc., Nemko can help you to get the required CE certification. By affixing the CE marking, the manufacturer / its representative/importer assures that the Product meets all the essential requirements of all applicable EU directives. Examples of European Directives requiring CE marking include toys, medical devices, machinery, low voltage equipment, Radio & Telecom equipment, etc. For most products, the CE marking is essentially based on the manufacturer’s own declaration of conformity with the relevant directives (without the involvement of notified body).
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 mark 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 Certification. 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.
For more information about how Nemko can help your organization with CE certification as well as a required declaration (involvement of notified body or not), contact us or mail us at firstname.lastname@example.org or give us a call at +91-9205690574.
Want to learn more? Watch this short (5 min.) introduction video: