Regulatory EMC & Wireless Testing

CE Mark & UKCA Compliance Testing

Rely on Elite as your compliance partner to make sense of the Directives, Regulations, Harmonized Standards, and Conformity Assessment Processes.

Elite's Connected Conformity Process for CE and UKCA Marking

Elite provides CE Marking testing and type-approval for electronic and wireless devices, ensuring compliance with EU and UK regulations. We streamline the process, saving manufacturers time and costs while ensuring market readiness. From assessment to certification, we define required tests, documentation, and labels. With our partner, Global Validity, we also support global market access and ongoing compliance.

European Union CE 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/EURadio Equipment Directive
2014/30/EUEMC Directive
2014/35/EULow Voltage Directive
93/42/EECMedical Devices Directive
2006/42/ECMachinery 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 55035Emissions and Immunity for ITE
EN 61326-1Measurement, Control, Lab Use
EN 60601-1-2Medical Electronics
EN 55014-1 & EN 55014-2Household Appliances, Tools, and Similar Apparatus
EN 61000-6-xGeneric EMC Standards
EN 301 489-xRadio 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

Contact Our CE and UKCA Compliance Specialists

Elite’s experts are readily accessible! Clients can easily connect with our team to discuss compliance questions and learn about relevant regulations and services. We review your product and its application to determine the required scope and develop a tailored testing and service plan. Our team leaders then prepare you for testing and confirm conformity details. We guide you through every step of the process.

Luke Morrill

Technical Sales Engineer

Steve Laya

Sales and Marketing Manager

Richard King

Certification Department Supervisor / Regulatory EMC Team Leader

FREE eBook

Guide to CE Marking & RE Directives for Low-Power Wireless Transmitters

Regulatory Compliance News

March 5th, 2025

August 1, 2025 Deadline for CE Mark Cybersecurity

Manufacturers of wireless-enabled products will need to comply with new cybersecurity regulations under the Radio Equipment Directive (RE-D) 2014/53/EU. Learn more.
January 30th, 2025

Elite Upgrades to New CMX500 5G Signaling Box

Elite has recently acquired the CMX500, a high-performance 5G New Radio (NR) test solution designed to meet the evolving demands of modern communications. Read on.
October 18th, 2023

CE Mark Can Be Used Indefinitely for UK Compliance

Transition from CE Mark to UKCA has been extended indefinitely, giving manufacturers a choice for UK compliance. Learn more.
September 27th, 2022

FCC Now Requires Detailed Antenna Information for Transmitter Certifications

The FCC is requiring more antenna details on Part 15 Transmitter applications. Learn more.

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