The CE Marking Association offers membership to companies who want support on CE Marking on a regular basis. Members are invited to ask questions and when there is a question that might be of interest to a wider audience, we like to publish them in our news section. Some of the details may have been altered for confidentiality reasons.

Your Question

We are looking to use a ‘tracking device’ which has been externally sourced. We obtained a CE declaration for the pre-production unit, but changes have been made to the original CE certified model, such have incorporating battery management components and it now features a tamper alert system. We believe that this is a significant modification and therefore where expected to be provided with a new CE declaration. The suppliers say it is covered by the original CE declaration. Is this correct?

Answer

It is possible to cover many variants on the same Declaration of Conformity. You may wish to check that this variant is listed separately on the DofC to the original. Else a new Declaration is required specifically for this variant.

If you need any support with Declarations and CE marking, then please contact us on 01564 792349.

UPDATE: The new Directives have now come into force – New Declarations should now be quoting the new Directives.

The date for when the new 2016 CE marking Directives are coming into force is fast approaching and now is the time to make sure that you are prepared for the changeover.

From the 20^th April 2016, the new Directives will come into force, requiring manufacturers, distributors and importers to comply with the new requirements. The changes for most are not expected to be vastly different from a technical or engineering point of view, but are more likely will require some administrative changes.

The Directives affected on the 20^th April will be:

– Low Voltage Directive
– ElectroMagnetic Compatibility Directive
– ATEX Directive
– Lifts Directive
– Simple Pressure Vessels Directive
– Measuring Instruments Directive
– Non-automatic Weighing Instruments Directive
– Civil Explosives Directive

The intent of the changes, are to ensure that all CE marking Directives are aligned to the new framework, giving a greater level of consistency across all of the Directives. Therefore the Directives will be using the same terminology and definitions, and the conformity assessments modules will be similar, however there several key changes:

– Risk Assessments forming part of the conformity process

The new Directives now state that an adequate analysis and assessment of the risks must now be included within the technical documentation. Previously under many of these Directives, the requirement to undertake a risk assessment was not explicit, however it is now a clear requirement. The risk assessment should identify the hazards that are applicable to the product and then for the manufacturer to use this information to help identify essential requirements of the Directive and any standards that can be employed to reduce or eliminate the risks. You can read more about risk assessments on a separate article here.

– New format for the Declaration.

Along with the new Directives comes a new Declaration, titled the ‘EU Declaration of Conformity’. The new Declaration not only has a new title (changing the letters ‘EC’ to ‘EU’) but also has a new format. Using the words from the new Low Voltage Directive, the new Declarations “shall have the model structure set out (within the Directive)”. This means that the Declarations are likely to be the most obvious sign whether a company is aware of the new changes or not. We strongly recommend that manufacturers ensure that their Declarations are updated ready in time for the 20^th April. We have generated some guidance on Declarations here.

– Economic Responsibilities are now clear.

The final key change is the inclusion of CE Marking requirements for other types of ‘Economic Operators’ other than manufacturers. Previously the requirements for importers and distributors was not always made very clear and was often left to information within guidance notes. Now the new Directives contain specific requirements for all of the different types of economic operators. If you are looking for assistance, we are running an ‘importers CE marking workshop’, and you can find more information on our public training calendar.

As part of the new Low Voltage Directive (2014/35/EU), manufacturers are required to include an ‘adequate analysis and assessment of the risk(s)’ for their equipment within the technical files. What this really means is that a Risk Assessment should be undertaken as part of the conformity process. Product Risk Assessments have been around for a number of years now with the Machinery, ATEX, and Medical Devices Directive all having them as a requirement, but will now become a common requirement across all of the new 2016 CE Marking Directives.

The purpose of the risk assessment is to help manufacturers identify the hazards relevant to their products and to use this information to help identify the applicable essential requirements of the Directive and any standards that can be employed to reduce or eliminate the risks (as illustrated in the diagram below). Whilst risk assessments can be subjective, there is guidance available to help manufacturers through the process.

CENELEC is European Committee for Electrotechnical Standardisation and they have released a guide that provides key information for what these risk assessments for electrical safety should entail. It gives details of the risk assessment process, as well as examples of potential hazards associated with electrical and electronic equipment and even guidance on the scoring system too.

The CENELEC guidelines for safety related risk assessment and reduction under the Low Voltage Directive can be found at: ftp://ftp.cencenelec.eu/CENELEC/Guides/CLC/32_CENELECGuide32.pdf

The ‘Blue Guide’ is a publication by the European Commission that offers CE Marking information and advice on the implementation of EU product Directives. The original document had a blue front cover, which gave birth to the informal name, and covered many of the older versions of the EU Directives. It was updated in 2014 and released officially as the ‘Blue Guide’ for the first time.

A refreshed version of the guide, first published in 2000, has become available from the European Commission. The changes are minimal, but the latest version has been released in time for the 20^th April deadline for when the new Directives are coming into force.

If you require any assistance with CE Marking, then please get in touch with our team at 01564 792349. Alternatively you can complete our online enquiry form.

There is a new CE Marking Directive being implemented for radio equipment.

The Radio Equipment Directive (2014/53/EU), which will be effective as of the 13^th June 2016, will repeal the Radio & Telecommunications Terminals Equipment Directive (1999/5/EC). The new directive is part of a series of directive changes which have come about in order to align in a common framework in the EU Decision No. 768/2008/EU and will have a transitional period extending to the 13^th June 2017.

This means that products that are compliant with the R&TTE directive which have been placed on the market before 13^th June 2016 are compliant until 13^th June 2017. Any new products coming onto the market after 13^th June 2016 must meet the new RED criteria if they come under the scope of the Radio Equipment Directive.

There are a number of changes between the old R&TTE Directive and the new Radio Equipment, so it is worth being prepared before the new Directive comes into force. A key change is that the RED excludes telecommunications terminal equipment (as these are now covered by the Low Voltage and EMC Directives) but there are other changes to the directive which include: