CE Marking Directives (EMC Directives, PED, ATEX, Machines, CPR, LVD, R&TTE, RED, Sanitary Products, RoHS, Power Efficiency)
Ensure safety and reliability, meet regulations and standards:
The CE marking of complex systems presents certain difficulties that require a solid expertise in order to achieve the objective without jeopardizing the time-to-market and increasing the cost of the solution. Complex systems are composed of several subsystems, result of the integration of products of different nature, type and origin, and subject to different directives.
By stating the compliance of the product with the CE marking regulations, by means of the CE marking and the EC Declaration of Conformity, a manufacturer declares, on his sole responsibility, that the productmeets all the European legal requirements and that the conformity assessment procedure necessary to verify the conformity of the product to all the relevant essential requirements of the applicable directives has been carried out.
There are currently more than twenty CE marking directives, those most relevant to this type of systems are summarized below:
EVALUATION OF CONFORMITY
|Machinery directive, 2006/42/E||To ensure in the EU the health and safety of persons, in particular of workers and consumers and, where appropriate, of domestic animals and goods, notably in relation to the risks arising out of the use of machinery|| ||Where the machinery is not referred to in Annex IV of MD (*), the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII. |
The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the machinery with the technical file referred to in Annex VII, part A, and with the requirements of the MD.
|Low Voltage Directive, 2006/95/ECFrom 20 April 2016: 2014/35/EU||Electrical equipment within certain voltage limits both is safe in its intended use and enjoys a Single Market in the European Union||Electrical equipment with a voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current||No third party intervention is required, the manufacturer undertakes the conformity assessment. Products are presumed to conform to the safety requirements if manufactured according to harmonized standards.|
|Electromagnetic Compatibility Directive, 2004/108/ECFrom 20 April 2016: 2014/30/EU||The aim of the EMC Directive is to guarantee the free movement of apparatus and to create an acceptable electromagnetic environment in the European Community. That means to regulate the compatibility of equipment regarding EMC||A vast range of equipment encompassing electrical and electronic appliances, systems and installations. |
Mobile installations are classified as apparatus
|Apparatus. There is no compulsory involvement of a third party, but the manufacturer has the option of presenting his technical documentation to a Notified Body for assessmentFixed installations. Require neither an EC Declaration of Conformity (DoC) nor CE marking, however the application of good engineering practice is required.|
|Pressure Equipment Directive, 97/23/ECFrom 20 April 2016: 2014/68/EU||Harmonize national laws of Member States relating to the design, manufacture, testing and conformity assessment of the Pressurized equipment.||Pressurized Equipment with maximun pressure higher than 0,5 bar.|| |
In the PED, the pressure equipment is classified in different categories (ranging from I to IV), according to the level of hazard, being level IV the most hazardous category.The following are the modules applicable to the different categories:I = Module AII = Module A1, D1, E1III = Modules B1 + D, B1 + F, B + E, B + C1, HIV = Modules B + D, B + F, G, H1
The process to achieve CE marking for a complex system is depicted below. Compliance must be addressed from the very onset of the project so as to obtain CE marking in an easier and effective way.
The new directives that came into force on the 20th April 2016 are the following:
|New EMC directive||New LVD directive|
Most important changes:
- Alignement of EMC and LVD directives with the New Legislative Framework.
- The scopes of both directives don´t change except for the following exemption introduced in both directives:
- custom built evaluation kits destined for professionals to be used solely at research and development facilities
- As a consequence of the changes introduced in the RED directive, EMC and LVD directives will be applicable to telecom terminal equipment.
- Technical requirements practically don´t change. Conformity assessment procedures are adapted to NLF terminology.
- In general, more obligations for all economic operators (manufacturer, authorised representative, importer and distributor) are introduced, although the most important change is for the distributor, role not present before in the CE marking regulations.
- Measures to be taken by manufacturer, importer and distributor are stated in case of non-conforming products placed on the market.
- Products must be identified with type, batch or serial number to allow traceability. Also, manufacturers, and, where appropriate importers, shall indicate, on the apparatus, their name and the postal address.
What to do with already CE-marked products?
There is not transitional period:
Products placed on the market PRIOR to 20th April 2016 must declare conformity with “old directives” 2004/108/CE and 2006/95/CE.
Products placed on the market AFTER 20th April 2016 must declare conformity with “new directives” 2014/30/EU and 2014/35/EU.
Consequently, declarations of conformity (DoC) of products placed on the market prior to 20th April 2016 shall be updated. Check that the declaration contains all the information required by the new directives. A model structure is included in annex IV.
Don´t forget you should continuously verify that the harmonized standard(s) used for the conformity assessment and listed in the DoC has (have) not been withdrawn. Otherwise it (they) will not provide presumption of conformity with the directive.
RADIO EQUIPMENT DIRECTIVE 2014/53/EU (RED)
- “Old” R&TTE directive is repealed by the “new“ 2014/53/EU directive (RED)
- RED is a CE marking directive that incorporates the New Legislative Framework (NLF) requirements.
- It applies ONLY to radio equipment, including radiodetermination equipment. Telecom terminal equipment that does not function using radio will be under the scope of EMC and LVD directives (where applicable). TV & radio receivers are now specifically included in the scope of the RED.
- In general, more obligations for all economic operators (manufacturer, authorised representative, importer and distributor) are introduced.
|New directive is applicable and R&TTE directive is repealed||On 13th June 2016|
|New products must declare conformity with RED if placed on the market||After 13th June 2016|
|Products that declared conformity with R&TTE before 13th June 2016 can be placed in the market.||Until 13th June 2017|
What to do with existing products?
Products assessed under the R&TTE directive before 13th June 2016 can be placed on the market until 13th June 2017.
After this date these products must declare conformity with the new RED directive unless not longer in the RED scope (e.g. telecom terminal equipment.).
An impact analysis has to be performed to identify which activities have to be carried out to comply with the new RED. Take into account that tests performed to assess conformity with R&TTE directive can be used in the conformity assessment of RED if the same harmonized standard continues providing presumption of conformity now with RED.
Check that the new traceability and identification requirements are met and that the equipment is accompanied by instructions in a language which can be easily understood by consumers.
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