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 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 |
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
