CE Marking Requirements: Simplifying Compliance for Your Business
Vijay Tech & Business Solution: Your Expert Guide to CE Marking Certification and Compliance. Our in-depth resource simplifies the process of achieving CE Marking for your products, ensuring they meet all necessary European Union standards. From understanding legal requirements to navigating technical documentation, we provide step-by-step guidance to help businesses comply with EU regulations. Whether you’re entering the European market for the first time or need assistance with certification, our expert team is here to support your journey, ensuring a smooth, hassle-free path to successful CE Marking and market entry.
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 Vijay Tech & Bussiness Solution. 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 Vijay Tech &Bussiness Solution do?
Both as a test- and certification body and as a notified body Vijay Tech & Bussiness Solution can do the necessary work in order for you to do the required declaration and CE marking. Vijay Tech & Bussiness Solution 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, Vijay Tech & Bussiness Solution can issue the certificates required.