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The New Legislative Framework (NLF) for Directives


Please Note


Under the New Legislative Framework the revised directives are now in force. The UK government has an obligation to enact these directives into UK law however this process has been delayed and is not expected to take place until late 2016.

Guidance from The Department for Business, Innovation and Skills (BIS) advises that economic operators should comply with the requirements of the new directives from 20th April 2016 and products placed on the market after this date should be compliant with, and consequently have a declaration of conformity against, the new Directives.

Summary


On March 29, 2014, the European Commission published the recasts of eight CE marking directives. These directives have new reference numbers and are aligned with the rules and responsibilities for CE marking that were published earlier in the NLF's defining documentDecision 768/2008/EU. These Directives came into force on 20th of April 2016 as part of a ongoing alignment of all the CE marking directives.

The intention of this New Legislative Framework (NLF) is to:

  • provide better overall coherence and consistency across the range of directives;
  • improve market surveillance rules to provide better protection for consumers and professionals from unsafe goods;
  • clarify the notification process;
  • improve the accreditation of conformity assessment bodies and the conformity assessment procedures (modules);
  • clarify the meaning of the CE mark and enhance its credibility
  • clarify the obligations of importers and distributors where the manufacturer of the CE marked product is based outside Europe.


History


The introduction of the ‘New Approach‘ framework to European directives in the 1980s was intended to restrict the content of the directives to essential requirements and for harmonised standards to provide the technical details. To improve the acceptability of these directives across the EU, the European Council adopted a resolution for a 'Global Approach' which laid down general guidelines and procedures for conformity assessment. To further improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU Market a further review of the Global Approach resulted in a package of measures known as the 'New Legislative Framework'. This was adopted in July 2008 and came into force in January 2010.

Directives Affected


The package of eight directives which come into force on 20th April 2016 are:

The following have been previously aligned with the NLF:

The Radio and Telecommunications Terminal Equipment Directive (R&TTE) was replaced by the Radio Equipment Directive (RED) on 13th June 2016.

The following two realigned directives will come into force soon:

Further aligning proposals are pending on the Medical Devices, Gas Appliances, Cableways, and Personal Protective Equipment directives.

The majority of the differences introduced by the updated directives are concerned with implementing the principles of the NLF, but the legislators also took the opportunity to update some of the technical details of the affected directives. Generally, these changes are intended as clarifications and there are no fundamental changes to the scope or requirements of the directives. (Details of the technical changes and the implementation dates can be found on the relevant directive page elsewhere on this site).

Economic Operators


The New Legislative Framework creates common responsibilities across all of the new directives for 'Economic Operators' (i.e. manufacturers, authorised representatives, importers and distributors) responsible for placing goods on the market and specifies their responsibilities.

Definitions of Economic Operators are as follows:

  • ‘manufacturer’* means any natural or legal person who manufactures CE marked equipment or has CE marked equipment designed or manufactured for him, and markets that equipment under his name or trade mark;
  • ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
  • ‘importer’ means any natural or legal person established within the Union who places CE marked equipment from a third country, on the Union market;
  • ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes CE marked equipment available on the market;

*Note that under the definition of 'manufacturer', if you own brand label products you will effectively become the manufacturer and acquire all the associated responsibilities under the applicable directives.

As already noted, for most of the recast Directives that have been aligned with the NLF, there are no real changes for manufacturers who are already properly CE marking their products and the process is pretty much the same as under the old Directives, providing that they follow the general principles as set out in Article 30 of Regulation (EC) No 765/2008. However, for importers and distributors, there are new obligations which they must comply with.

Obligations


Manufacturers Must;

  • Ensure product meet the essential safety objectives.
  • Create a Technical File and follow the relevant conformity assessment procedure.
  • Keep the Technical File and Declaration of Conformity for 10 years.
  • Have quality procedures in place to ensure consistency of manufacture and to maintain of conformity with the directive(s). The procedures must cover changes in production, components, standards etc.
  • Carry out sample testing where this is considered appropriate to the risk presented by the equipment.
  • Investigate and log non-conforming product, complaints, recalls and inform distributors of such monitoring.
  • Apply marking that must include type, batch or serial no. or other means of unique identification, registered name or trademark and postal address.
  • Provide instructions, safety information and labelling which is in suitable, clearly understood, intelligible form and translated into the language(s) of the country of sale. Manufacturers are encouraged to include a web address but must not rely on on-line resources for the delivery of safety related information.
  • Be able to supply details of suppliers and customers upon reasonable request by an enforcement authority. Records must be kept for 10 years after supply or sale.
  • Take immediate action to correct, withdraw or recall non-conforming product.Product Recall checklist
  • Inform the relevant national authority if the non-conforming product presents a risk.
  • Provide information or documentation in paper or electronic form if requested.
  • Co-operate with authorities on any action to eliminate the risks posed by CE marked equipment which they have placed on the market.


Importers must:

  • Only supply compliant products.
  • Ensure the manufacturer has followed the correct and appropriate conformity assessment procedure, has drawn up technical documentation, affixed the CE mark, provided any necessary instructions and safety information and applied the correct marking.
  • Not place non-conforming product on the market, and inform the manufacturer and the relevant national authority if non-conforming product presents a risk.
  • Indicate on the equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the equipment. The contact details must be in an easily understood language(s).
  • Ensure instructions, safety information and labelling is provided in a form which is in suitable, clearly understood and translated into the language(s) of the country of sale.
  • Ensure that storage and transport conditions do not jeopardise conformity of the equipment.
  • Carry out sample testing where considered appropriate to the risk presented by the equipment, keep a register of complaints and recalls and keep distributors informed about these activities.
  • Be able to supply details of suppliers and customers upon reasonable request.
  • Take immediate action to correct, withdraw or recall non-conforming product.Product Recall checklist
  • Keep copies of the equipment’s Declaration of Conformity and ensure that this and the manufacturer’s technical file can be made available to the relevant enforcement authorities for 10 years after the last date on which the product is sold.
  • Provide information or documentation in paper or electronic form if requested.
  • Co-operate with authorities on any action to eliminate the risks posed by equipment which they have placed on the market.


Distributors must:

  • Only supply compliant products.
  • Verify that the equipment bears the CE marking and is accompanied by the required instructions, marking (including identification of the manufacturer and/or importer) and safety information, in the correct language(s).
  • Not place non conforming product on the market, and inform the relevant national authorities if non conforming product in their possession presents a risk.
  • Ensure that storage and transport conditions do not jeopardise conformity of the equipment.
  • Take any corrective action required to ensure that non-conforming product which they have sold is made to conform, or where appropriate to recall or withdraw it from the market.
  • Immediately inform the relevant national authority if the non-conforming product presents a risk
  • Provide information or documentation in paper or electronic form if requested.
  • Co-operate with authorities on any action to eliminate the risks posed by CE marked equipment which they have placed on the market.


The NLF also has requirements for Notified Bodies, Notifying Authorities and Enforcement Authorities.

This summary is designed to provide you with a general overview of the topic. If you require any further help or guidance please contact us.

Further advice


For further advice specific to your products, please contact us at Conformance and we will be pleased to help.

new_legislative_framework_nlf.txt · Last modified: 2016/06/13 14:17 by Sarah Hall
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