Elite's Connected Conformity Process for CE and UKCA Marking
Elite can test and type-approve for CE Marking of electronic and wireless devices to meet European Union Directives and UK Regulations. Our services offer manufacturers convenience, cost savings, and assurance that their products are compliant and ready for market in a timely manner.
Elite’s Connected Conformity Process- Takes you from start-to-market. We begin by understanding your product and its application, then we outline a plan for your conformity steps and define the tests, documents, labels, and information you will need to become compliant and market ready. We certify your products when necessary and help you broaden you reach with our global market access partner Global Validity. Lastly, we will help you remain compliance when your product or the compliance requirements change.
Start by Contacting Our CE and UKCA Compliance Specialists
Elite’s experts are accessible! Clients can easily connect with our staff to discuss compliance questions and learn about regulations and services. We review your product and application to determine the scope of requirements and to develop the suite of testing and services. Next, our team leaders prepare the client for testing and confirm conformity details. From there, we guide the process through any related services, and continue all the way to conclusion and market access.
Edwin Casas
EMC Test Engineer
Steve Laya
Sales and Marketing Manager
Richard King
Certification Department Supervisor / Regulatory EMC Team Leader
Regulations, Compliance News, and More
European Union CE Marking
United Kingdom UKCA Marking
European Union Directives and Harmonized Standards
There are nearly 30 New Approach Directives in the European Union that establish the essential requirements for a wide range of manufactured products. The Directives provide a framework for compliance by defining the scope of applicability and by specifying the conformity assessment processes, along with many other legal and administrative details. When manufacturers meet all applicable Directives they signify compliance by labelling their products with the CE Mark. Several of the Directives that Elite offers servicers are:
| 2014/53/EU | Radio Equipment Directive |
| 2014/30/EU | EMC Directive |
| 2014/35/EU | Low Voltage Directive |
| 93/42/EEC | Medical Devices Directive |
| 2006/42/EC | Machinery Directive |
While the Directives provide the framework and overview of the CE Marking obligations, the technical requirements are specified in Harmonized Standards called Euro-Norms (EN’s). These ENs are developed through consensus by Standards Development Organizations (SDOs) such as the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and Comite International Special des Perturbations Radioelectriques (CISPR). Manufacturers that comply with EN harmonized standards in full are afforded the presumption of conformity for their products. Several common and important Harmonized Standards include:
| EN 55032 & EN 55035 | Emissions and Immunity for ITE |
| EN 61326-1 | Measurement, Control, Lab Use |
| EN 60601-1-2 | Medical Electronics |
| EN 55014-1 & EN 55014-2 | Household Appliances, Tools, and Similar Apparatus |
| EN 61000-6-x | Generic EMC Standards |
| EN 301 489-x | Radio Equipment EMC |
United Kingdom UKCA Regulations
The United Kingdom (UK), in particular England, Wales, and Scotland have a regulatory compliance process that is separate from that in the European Union. While being separate, the regulatory processes are very similar and the UK technical standards are identical in nearly all cases to EN standards for CE Marking. Manufacturers that establish compliance with the UK regulations through harmonized standards or other means label their products with the UKCA mark.
| Electromagnetic Compatibility Regulations 2016 |
| Electrical Equipment (Safety) Regulations 2016 |
| Radio Equipment Regulations 2017 |
| Supply of Machinery (Safety) Regulations 2016 |
| Medical Devices through EU Directive 93/42/EEC |
IMPORTANT UPDATE- Read Elite’s Blog about news on the UKCA Marking, and the Indefinite use of the CE Mark in the UK!
Related Regulatory Services
CE Mark and UKCA Regulatory News
Technology changes rapidly and so do the government and industry requirements that regulate the use of wireless and digital devices. Stay current on the latest information on regulatory compliance and link to news and updates below.
Products placed on the market in England, Wales, and Scotland must be UKCA marked by Jan 1, 2025.
As an European Union and UK Notified Body Elite attends all REDCA meetings meeting to maintain our expertise and stay abreast of the latest regulatory news and information. We distilled many of the meeting highlights in our recent Webinar and blog. Read more.
Advances in WiFi technology will bring nearly 1GHz of new bandwidth in the 6GHz range. Elite has invested in the WiFi test equipment necessary to evaluate WiFi transmitters for European Union compliance certification . Learn how we can help you get your products to market.
