EU Directives

Three new Directives for the electrical sector have been published and are now in effect: the EMCD (Directive 2014/30/EU), the LVD (Directive 2014/35/EU) and the RED (Directive 2014/53/EU). When comparing these directives to the previous version you will find that many changes were made, particularly to the RED and its applicability to certain product families. Unfortunately the changes are numerous enough that we cannot summarize them all. There has been some confusion as to the date of applicability and transitional period for these new Directives, so the purpose of this article is to try to provide some guidance.

New EMC Directive 2014/30/EU

Since 20 April 2016, the new European Union EMC Directive 2014/30/EU is now in effect and the previous EMC Directive 2004/1008/EC has been withdrawn. The new directive is a “recast” directive and does not change the scope or essential requirements as related to the current directive it replaces (except for changes introduced in the scope of the RED that affect the EMC Directive).

The new EMCD applies to products “placed on the market”* on or after 20 April 2016.
(* For definition of “placed on market” see “Placing on the Market” section below)

Many former requirements remain the same and are listed in Annex 1. Some of the changes are identified below:

• The EMC Directive now formally applies to importers, designated representatives, and distributors as well as to manufacturers.

• There are additional technical requirements regarding detailed documentation required for the technical file including manufacturing drawings and conceptual designs related to components and circuitry used in the device, including sub-assemblies, along with any explanations needed for operation and use of the device as intended. The technical file is required to be available for 10 years after the product or device is placed on the market.

• Declaration of Conformity (DoC) must be in the official language or languages of the member states where the devices or product is placed on the market. It must be updated to reflect the new EMC Directive number 2014/30/EU. A review of the standards used for compliance is strongly suggested to ensure the current standards, revisions and relevant dates are properly identified.

  What I (Donald Sweeney) would do as of 2/1/2017:

  For EMC and LVD, issue your DoC (in English) as directed in the link given by the commission. (See example given below under “Making a new DoC.”) Do not include it with your product, but keep it with your technical file.

  If it is requested from the authorities, see if they will take the English version and if not, have it changed ASAP (within 2 days) to the required language.

  I would issue instruction manuals in all languages of the EU. I would do this by having them in a single manual, such that you are sure the manual contains the language of the country the product is being sold in.

New Low Voltage (Safety) Directive (LVD) 2014/35/EU

A new LVD Directive 2014/35/EU was published in the Official Journal of the European Communities on 29 March 2014. It replaces the previous version (2006/95/EC) and became effective on 20 April 2016. It is a “recast” directive and does not change the scope or essential requirements as related to the current directive it replaces (except for changes introduced in the scope of the RED that affect the LVD Directive).

The new LVD is applied to products “placed on the market”* on or after 20 April 2016.
(* For definition of “placed on market” see “Placing on the Market” section below)

A brief summary of the most significant LVD changes follows:

• Market surveillance procedures were added

• The LVD now clearly indicates that the product manufacturer is solely responsible for preparation of the documentation for CE marking, preparation of the EU Declaration of Conformity (DoC), making sure all directives/EU requirements applicable to the product are covered when affixing the CE mark

• The option for intervention of a Notified Body was removed

• Text was added to indicate that the DoC needs to be translated into the languages required by each EU country where the product is sold. (See Declaration of Conformity under EMC Directive.)

• The manufacturer is now required to only keep the applicable documentation and DoC for 10 years after placing the actual product on the market

• Internal production control was designated as the main conformity assessment procedure

• The technical documentation is now required to also include analysis and assessment of all foreseeable risks associated with the product. This can be a major project.
• A change in scope now includes protection of health of people, animals, and property, including risks from the use of any electrical equipment, including those that are mechanical or chemical in nature

• New references to risks that are related to noise, vibration, and ergonomics must be addressed

New Radio Equipment Directive (RED) 2014/53/EU Now in Effect

The new Radio Equipment Directive 2014/53/EU (RED) replaces the R&TTE Directive 1999/5/EC. The RED is now in effect and only applies to products placed on the market/put into service on or after 13 June 2016. There is a 1-year transition period applicable for this Directive that applies as follows:

For products within the scope of the current R&TTE Directive and which remain within the scope of the RED:

• For products placed on market* between 13 June 2016 and 12 June 2017, you may use either the R&TTED or RED
• For products placed on market* after 12 June 2017, use only the RED, updating all R&TTE to RED or what is applicable

(* For definition of “placed on market” see “Placing on the Market” section below)

For products currently within the old & new LVD & EMCD that fall within the RED beginning 13 June 2016 (i.e. TV and sound broadcast receivers):

• For products placed on market* between 13 June 2016 and 12 June 2017, the RED or new LVD/EMCD may be used
• For products placed on market* after 12 June 2017, use only the RED

(* For definition of “placed on market” see “Placing on the Market” section below)

For products currently within the R&TTE Directive but will be outside the RED (i.e. Wired Terminal equipment):

• For products placed on market* after 12 June 2016, the RED is not applicable to these products; therefore, the new LVD/EMCD (if applicable to the product in question) must be used

(* For definition of “placed on market” see “Placing on the Market” section below)

Most important are the changes in the scope of the RED, which will only apply to radio products. The provisions for Telecom and Terminal Equipment are no longer referenced in the RED. Broadcast receivers will fall under the provision of the RED directive as well.  The RED covers all essential requirements for EMC, Electrical Safety, and Radio & Radio Spectrum aspects of the product. Therefore, the EMC and Low Voltage Directives do not apply to radio products.

Some of the changes brought about by the new RED are listed below:

• Receive-only equipment is moved to the RED.

• Radio receiver minimum performance requirements contributing to the efficient use of radio spectrum now are included under the scope of the RED.  These apply to all receivers including broadcast radio and TV receivers.

• RED is for wireless equipment used for communication only.  Radio-determination equipment becomes explicitly included.

• There is no lower limit of the covered frequency range (for R&TTE, the lower limit was 9 kHz). The upper frequency limit remains at 3000 GHz.

• All wired TTE equipment is out of the RED and defaults to the EMC Directive.

• The notification procedure for radio equipment using non-harmonized frequency bands has been eliminated.

• Radio technical documentation must include confirmation of operation in at least one Member State without infringing requirements on the use of radio spectrum.

• Interworking with accessories such as common chargers can be invoked under Article 3.3 if decided by the European Commission.

• The RED includes better defined obligations and responsibilities for manufacturers, designated representatives, importers and distributors.

• The RED specifies strengthening of market surveillance, more sample testing of products by the manufacturer/importer, and a formal register of complaints, updates, and product recalls.

• The Notified Body Opinion (Annex IV of R&TTE Directive) is replaced by a “Type Examination”.  This procedure specifies that modifications made to products which affect compliance must be reviewed and agreed upon by the Notified Body.

• A Notified Body database will be established, in which Notified Bodies must record information specific to the certificate, including the scope, refusal, restrictions, suspension or withdrawal. All EU Member States must be informed of the Type Examination Certificate.

• Notified Body identification number is prohibited from being used in the CE marking on products which followed the Type Examination procedure.

• Notified Body number must be used in Declaration of Conformity where Full Quality Assurance procedure is followed.

“Placing on the Market”

Each individual serial number of a product is considered to be “placed on the market” when it is made available for the first time on the European Union Market and must comply with the harmonized legislation in effect at that moment. The “moment” is defined as when a manufacturer or importer supplies a product to a distributor or an end-user for the first time. This can only be done by a manufacturer or an importer. Any subsequent operation, for instance from a distributor to a distributor or from a distributor to an end-user, is defined as “making available” and not defined as “placing on the market.”

The concept of “placing on the market” refers to each individual product, not to a specific model of a product whether it was manufactured as an individual unit or in series. Consequently, even though a product model or type has been supplied before new European Union harmonization legislation laying down new mandatory requirements entered into force, individual units of the same model or type which are placed on the market after the new requirements have become applicable must comply with these new requirements.

Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question. This transfer could be for payment or free of charge. It does not require the physical handover of the product.

Making a new DoC

The commission has issued some significant changes to what you need to do to allow your product to have an orderly placement in the European Marketplace during 2016 and 2017. You will need to generate a new DoC.

There is a recommended DoC form on the following web location: 
http://ec.europa.eu/growth/sectors/electrical-engineering/emc-directive/index_en.htm#t_0_1
Click on Guidance and then ADCO Documents and Recommendations.
Or Click Here to Download (2016-01-04 example of EMC DoC). 

The real PDF file includes fillable form fields. You can print the completed form and save it to your device. I also believe this form can be modified to include any directive you need to add. -Don Sweeney

Until clearer direction is available from the commission, when placing a product on the market (see prior definition of “placing on the market”) just before or just after the expiration date, I (Donald L. Sweeney) would suggest that you include in your new DoC a statement such as one of the following:

For EMC:
“The object of the declaration described herein is in conformity with the relevant EU legislation EMC Directive 2014/30/EU.” See example DoC above.

For LVD:
“The object of the declaration described herein is in conformity with the relevant EU legislation Directive 2014/35/EU.” See example DoC above.

For RED:
See example of full DoC above.

·         A DoC is required for the RED (similar to the R&TTED).

·         Instead of the full DoC, supply the alternative simplified DoC with the product. A limited DoC is mandatory.

·         A version of the limited DoC, in all official languages of the EU that have been published, can be found in Annex VII of the RED and is also shown below.

·         Keep the full DoC in English only at your office (or your website).

It would not make sense to have the full DoC on your website in all EU languages. Only supply the full DoC if an authority requests it. If another language is required, then have it translated ASAP (as indicated in #1).

SIMPLIFIED EU DECLARATION OF CONFORMITY

The English version of the Simplified EU declaration of conformity referred to in Article 10(9) shall be provided as follows: “Hereby, [Name of manufacturer] declares that the Radio equipment type [designation of type of radio equipment] is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: [www. place manufacturer’s web address here.com]

For your convenience, D.L.S. has downloaded all official language versions of the RED directive, copied only Annex VII from each, and combined them all into a single Word document. If you follow the directions at the top of the page to substitute the 3 items you are required to fill in for each language, you will have your Simplified DoC for your product for the RED. Be sure to only copy the Annex VIIs (not the instructions at the top) into your form to be supplied with the product. Please confirm the Simplified DoC makes sense for your application. CLICK HERE to download your working form.

We suggest that you also add to the full DoC the rationale of why it meets the new directive.

CLICK HERE to go to our EU Blue Guide page to download the latest 26 July 2016 version.