NLF implementation in product legislation - agoria.be · Marc Cumps [email protected]...
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AGORIA Regulations & Standardisation NLF implementation in product legislation New obligations for all economic operators Marc Cumps Chief expert - Technical Regulations
Transcript of NLF implementation in product legislation - agoria.be · Marc Cumps [email protected]...
AGORIA Regulations & Standardisation
NLF implementation in
product legislation New obligations for all economic operators
Marc Cumps
Chief expert - Technical Regulations
New Legislative Framework (NLF)
• Regulation 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• Decision 768/2008 of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC
New Legislative Framework
• New Legislative Framework (NLF) Decision 768/2008
• Model for future product legislation
• Definitions
• Identification of economic operators and their responsibilities
• Set of conformity assessment modules (A – H)
• Criteria for designation and notification of conformity assessment bodies
NLF & its implementation
• Toys Directive 2009/46/EC
• RoHS Directive 2011/65/EU
• Pyrotechnic Articles Directive 2013/29/EU
• NLF Alignment package • Low Voltage Directive 2014/35/EU, Electromagnetic Compatibility Directive
2014/30/EU, ATEX Directive 2014/34/EU, Simple Pressure Vessels Directive 2014/29/EU, Lifts Directive 2014/33/EU, Measuring Instruments Directive 2014/32/EU, Non-automatic Weighing Instruments Directive 2014/31/EU, Civil Explosives Directive 2014/28/EU
• Radio Equipment Directive 2014/53/EU
• Pressure Equipment Directive 2014/68/EU
• Ongoing revisions : Gas Appliances Directive, Personal Protective Equipment Directive
Economic operators & obligations
• Economic operators : manufacturer, authorised representative, importer, distributor
• Manufacturer : Any natural or legal person who manufactures apparatus or has apparatus designed or manufactured, and markets that apparatus under his name or trade mark
• Authorised representative : 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 : Any natural or legal person established within the Union who places apparatus from a third country on the Union market
• Distributor : Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes apparatus available on the market
Economic operators & obligations
• Manufacturer
• Fully responsible for compliance as in earlier EU Directives
• e.g. technical documentation, conformity assessment procedure, declaration of conformity, CE marking, …
• Traceability requirements
• Product (e.g. type, batch, serial number)
• Manufacturer : name & postal address on product
• Information requirements
• Information/instructions, DoC, language requirements as in national transpositions
• Corrective actions and collaboration with authorities
Economic operators & obligations
• Authorised representative
• Written mandate from the manufacturer
• Can not take responsibility for design and establishing technical
documentation
• Minimum tasks within mandate
• Keep DoC and technical documentation
• Work with national authorities to demonstrate compliance or help to ensure
compliance
Economic operators & obligations
• Importer
• Place only compliant products on the market
• Ensure manufacturer has carried out its duties (conformity assessment
procedure, technical documentation, CE marking, documents, traceability)
• Indicate their name, registered trade name or registered trade mark and
postal address on the product
• If not possible, then on packaging or in documentation
• Keep DoC for (specified number of) years and ensure technical
documentation can be made available
• Corrective actions and collaboration with authorities
Economic operators & obligations
• Distributor
• Act with due care in relation to requirements
• Verification
• apparatus bears CE marking,
• apparatus is accompanied by required documents
• traceability requirements are respected
• Corrective actions and collaboration with authorities
Economic operators & obligations
• All economic operators
• Must be able to identify
• Any economic operator who has supplied them with a product
• Any economic operator to whom they have supplied a product
Manufacturers
(Man)
Authorised
representatives
Importers
(Imp)
Distributors
Shall draw up the technical documentation and carry out the relevant conformity
assessment procedure X (art.R2.2) No (art.R3.1)
X ensure that Man has
(art.R4.2)
Shall draw up an EU declaration of conformity and affix the CE marking X (art.R2.2) X ensure that Man has
(art.R4.2)
X verify CE
marking (art.
R5.2)
Shall keep the technical doc and the EU declaration of conformity for x (as specified
in the legislation) years X (art. R2.3) X (art. R3.2.a) X (art. R4.8) (copy
DoC + ensure tech. doc
can be made available)
Shall ensure that procedures are in place for series production to remain in
conformity X (art. R2.4)
When deemed appropriate with regard to the risks presented by a product, carry out
sample testing of marketed products investigate, and, if necessary, keep a register
of complaints, of non-conforming products and product recalls, and shall keep
distributors informed of any such monitoring
X (art. R2.4)
X (art. R4.6)
Economic operators & obligations
References
• New Legislative Framework
• Regulation 765/2008
• Decision 768/2008
• Guidance
• Blue Guide
• Sectoral guidance documents in preparation
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Annex : NLF – Obligations economic
operators
Manufacturers
(Man)
Authorised
representatives
Importers
(Imp)
Distributors
By a written mandate, in case of appointment of an authorised representative. X (art. R3.1) X (art. R3.1)
When placing on the market shall ensure that they have been designed and
manufactured in accordance with the essential requirements. X (art.R2.1) No (art.R3.1)
Shall place only compliant products on the market. X (art. R4.1)
Shall act with due care in relation to the requirements when making products
available on the market X (art. R5.1)
Consider or has a reason to believe that equipment is not in conformity with the
essential requirements, shall not place the equipment on the market until it has been
brought in conformity.
When the equipment presents a risk, the importer shall inform the manufacturer and
the market surveillance authorities .
X (art. R4.2) X (art. R5.2)
NLF :Obligations economic operators
Manufacturers
(Man)
Authorised
representatives
Importers
(Imp)
Distributors
Shall draw up the technical documentation and carry out the relevant conformity
assessment procedure X (art.R2.2) No (art.R3.1)
X ensure that Man has
(art.R4.2)
Shall draw up an EU declaration of conformity and affix the CE marking X (art.R2.2) X ensure that Man has
(art.R4.2)
X verify CE
marking (art.
R5.2)
Shall keep the technical doc and the EU declaration of conformity for x (as specified
in the legislation) years X (art. R2.3) X (art. R3.2.a) X (art. R4.8) (copy
DoC + ensure tech. doc
can be made available)
Shall ensure that procedures are in place for series production to remain in
conformity X (art. R2.4)
When deemed appropriate with regard to the risks presented by a product, carry out
sample testing of marketed products investigate, and, if necessary, keep a register
of complaints, of non-conforming products and product recalls, and shall keep
distributors informed of any such monitoring
X (art. R2.4)
X (art. R4.6)
NLF :Obligations economic operators
Manufacturers Authorised
representatives
Importers Distributors
Shall ensure that products which they have placed on the market bear a type, batch
or serial number or other element allowing their identification X (art. R2.5) X ensure that Man
has (art.R4.2)
X verify that
Man/Imp has
(art.R5.2)
Shall indicate on the product, their name, registered trade name or trade mark and
the postal address.
The contact details shall be in a language easily understood.
X (art. R2.6) X ensure that Man
has (art.R4.2)
X (art. R4.3)
X verify that
Man/Imp has (art.
R5.2)
Shall ensure that the product is accompanied by instructions and safety information,
in a language which can be easily understood by consumers and other end-users. X (art. R2.7) X (art. R4.4) X (art. R5.2)
Shall ensure that while a product is under their responsability, its storage or transport
condition do not jeopardise its compliance with essential requirements. X (art. R4.5) X (art. R5.3)
NLF :Obligations economic operators
Manufacturers Authorised
representatives
Importers Distributors
That have reason to believe that a product is not in conformity, shall take the
corrective measures necessary to bring that equipment into conformity, to withdraw
it, or recall it.
When the equipment presents a risk, shall immediatly inform the competent national
authorities of the MS.
X (art. R2.8) X (art. R4.7) X (art. R5.4)
Shall further to a reasoned request from a competent national authority, provide it
with all the information and documentation in paper or electronic form, necessary to
demonstrate the conformity of the product.
X (art. R2.9) X (art. R3.2.b) X (art. R4.9) X (art. R5.5)
Cooperate with the competent national authorities, at their request, on their request,
on any action taken to eliminate risks posed by products. X (art. R2.9) X (art. R3.2.c) X (art. R4.9) X (art. R5.5)
NLF :Obligations economic operators
Manufacturers Authorised
representatives
Importers Distributors
Shall be considered a manufacturer and shall be subject to his obligations, when he
places a product on the market under his name or trade mark or modifies a product
already placed on the market in such a way that compliace with the legislation may
be affected.
X (art. R6) X (art. R6)
Shall identify the following to the market surveillance authorities:
(a) any economic operator who has supplied them with a product
(b) any economic operator to whom they have supplied a product
Shall be able to present info for x (as specified in the legislation) years after they
have been supplied and have supplied with products.
X (art. R7) X (art. R7) X (art. R7) X (art. R7)
NLF :Obligations economic operators
