Generally speaking device ‘compliance’ is achieved by conforming to given rules, dictated by things such as specifications, policies, standards or the law. Regulatory compliance is a business goal covering the awareness and steps taken in order to comply with relevant laws, policies, and regulations. CE, FCC and the new UKCA certifications are the leading standards for regulatory compliance.
Mandatory conformity certification, or conformance is a process through which a Product passes ensuring that is has passed performance and quality assurance tests as well as complying to the specific qualification criteria that is stipulated in applicable regulations and “certification schemes”.
In Europe (now excluding the UK), for example, the conformity certification applicable is CE (Conformité Européenne meaning European Conformity) and is a clear marking recognisable worldwide. This conformance certification will clearly indicate adherence to health, safety and environmental standard for terminal devices sold throughout the European Economic Area.
In a similar fashion the FCC (Federal Communications Commission) Declaration of Conformity is used on specific electronic devices sold within the United States of America.
Numerous countries have their own standards for ‘CE’ certification testing.
The CE marking directives are written into European law with the directives converted into each EU member state’s national law. Failure to comply will incur penalties which will differ depending upon the location of the business and, if financial, will have to be paid in the local currency.
On 1st January 2021 the UKCA (UK Conformity Assessed) marking will come into use for goods sold into the UK market. This new marking will cover most goods previously requiring the CE (Conformité Européenne) mark.
The UK government website www.gov.uk states:
The UKCA marking can be used from 1 January 2021. However, to allow businesses time to adjust to the new requirements, you will still be able to use the CE marking until 1 January 2022 in most cases.
In some cases you will need to apply the new UKCA marking to goods being sold in Great Britain immediately from 1 January 2021. You are encouraged to be ready to use the UKCA marking as soon as possible before this date.
The CE marking will only be valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and you CE mark your product on the basis of those new rules you will not be able to use the CE marking to sell in Great Britain even before 31 December 2021.
IoTAS can offer guidance and support to assist you with achieving new UK conformance as well as converting your existing CE declarations to UKCA.
The Radio Equipment Directive (RED) establishes a regulatory framework for placing radio equipment on the market. The Radio Equipment Directive ensures a Single Market for radio equipment by setting essential requirements for safety and health, electromagnetic compatibility, and the efficient use of the radio spectrum. It applies to all products using the radio frequency spectrum. The Directive requires equipment to be constructed for efficient use of the radio spectrum, as well as electromagnetic compatibility, to avoid interference with terrestrial and orbital communications.
All product in scope of this directive and placed on the EU market must be compliant with this directive from June 13, 2017. RED repeals the Radio and Telecommunications Terminal Equipement (R&TTE) directive since June 13, 2016.
IoTAS have successfully managed numerous RED approval processes and can offer full consultation delivery programming for customers wishing to achieve this regulation standard, including harmonisation management. We would also advise that if you are intending to place a new radio enabled product on the market, continuing to market an existing radio product, installing a radio module into your product, or re-branding someone else’s radio product then you should be adhering to Radio Equipment Directive.
Radio and telecommunications terminal equipment require CE & UKCA conformity and marking as dictated by this directive. IoTAS can assist in the goal of achieving CE & UKCA compliance certification and have provided this service (CE) to customers who are seeking approval. With our knowledge and experience we have developed a guideline process to ensure success: