What is the New Legislative Framework (NLF) for CE mark? The EMC directive for CE compliance has been around for many years the older redundant directive 2004/108/EC was replaced with 2014/30/EU. The 2014/30/EU is now in affect for CE EMC testing. This directive immediately replaced to the older directive as per 20th April 2016.
The 2014/30/EU directive attempts to address issues that were apparent in the EU market relating to ensuring that only CE compliant products are sold on the EUT market. Previously there was little if no trace-ability for products and as such distributors would sell products that were bought in the EUT which had no identification of the manufacturer of the importer. This was issue was further compounded by the emergence of online companies that refuse to accept any responsibility for sellers or vendors using their marketplace to introduce products directly from either inside the EU or from outside the EUT with in many cases no responsible party ensuring CE compliance. This can lead to defective, out of specification components, non compliant EMC design, electrical safety issues even counterfeit products that look and provide the same functionality as the real product but are in-fact sub-standard in many ways to the authentic product coming onto the EU market without any accountability. This has been highlighted in news stories were harm to persons or property has been documented.
So in order for the EU market to change it had to change both the framework and the relevant directives. The New Legislative Framework (NLF) was adopted by the EC on the 9th of July, 2008 and published in the OJEU on the 13th of August, 2008. This was the first major changed to the EU’s single market. And brought in to improve market surveillance rules, ensuring ‘CE marking’ credit-ability, allow help authorities and competitors take legal action against abuse of incorrect CE marking and create a template of legal measures for use in Directives.
So what has changed this year?
On the 20th of April, 2016 the following EU directives changes are as follows:
■ Electromagnetic Compatibility, 2014/30/EU (replacing 2004/108/EC)
■ Low Voltage, LVD, 2014/35/EU (replacing 2006/95/EEC)
■ Civil Explosives, 2014/28/EU (replacing 93/15/EEC)
■ Simple Pressure Vessels, SPV, 2014/29/EU (replacing 2009/105/EC)
■ Measuring Instruments, 2014/32/EU (replacing 2004/22/EC)
■ Lifts, 2014/33/EU (replacing 95/16/EC)
■ Explosive Atmospheres, ATEX, 2014/34/EU (replacing 94/9/EC)
■ Non-Automatic Weighing Instruments, NAWI, 2014/31/EU (replacing 2009/23/EEC)
Note: Toy Directive, 2009-48-EC, is already NLF’d and already fully in force (replaced 88-378-EEC) for some time now.
So what else will change in the future months or years?
Well there are still more up and coming directive changes such as:
■ Radio Equipment 2014/53/EU replaces R&TTE 1999/5/EC on 13 July 2016, with a transition period to 12 July 2017 only for certain products not previously covered by the R&TTE
■ Pressure Equipment 2014/68/EU replaces 97/23/EC on 19 July 2016
■ Marine Equipment 2014/90/EU replaces 96/98/EC on 18 Sept. 2016
■ Medical Devices and Active Implantable Devices Directives 93/42/EEC and 90/385/EEC will both be replaced by a single NLF’ Regulation probably between 2017 and 2021
■ In-Vitro Diagnostics Directive 98/79/EC will also be replaced by an NLF’d Regulation probably between 2017 and 2021
■ Personal Protective Equipment, proposal to replace 89/686/EC (mod’d 2004), but no dates yet
Council Regulation 765/2008/EC – Requirements for accreditation and market surveillance relating to the marketing of products……
765/2008/EU is the mechanism by means through assessment by laboratories, inspection bodies, certification bodies and verification bodies that government, purchasers and consumers have confidence that products and services available on the EU’s single market are fit for use i.e. they meet all the relevant specifications and legislation.
Council Regulation 768/2008/EC – Applies to ALL economic operators in a product’s supply chain
The term “economic operators” is an NLF term that defines manufacturers, authorised representatives, agents, distributors, importers and so forth that are in the products supply chain, this also includes distance selling i.e. outside the EU and also through electronic means such as online vendors.
The term “made available” is an NLF term meaning when an individual unit of a product is available on the EU market for distribution, hire, consumption or use and this is irrespective if the product is purchased or given free of charge,
The term “placed on the market” is an NLF term that means first made available on the EU market.
Brief analysis of actions required to comply with the New Legislative Framework (NLF) directives
Manufacturers must ensure that any product they make available for the EUT market conforms to the following:
- Is designed, manufactured and assessed so as to individually conform to all applicable EU Directives
- Has Technical Documentation which demonstrates compliance, which makes it possible to assess the product’s conformity to the relevant requirements. Including an adequate analysis and assessment of the risk(s) and is kept updated and available for 10 years after the product was last made available on the EU market. This technical documentation must contain the following:
The new “Risk Assessment” requirement in the NLF
The Risks concerned only relate to the Essential Requirements of the relevant Directives, such as:
EMC Directive (EMCD): Including risks that are EMI related either through emissions causing interference, or immunity related issues causing deviation to normal expected functioning, but no safety risks covered by EMCD.
Low Voltage Directive (LVD): Risks that are safety-related (electrical and non-electrical hazards to humans, domestic animals and/or property)
Radio Equipment Directive (RED): Risks that are radio related & safety related including Specific Absorption Rate testing (SAR) and other EMC related, regional variations etc.
Toy Directive: Risks that are related to harming children caused by toys
Administrative non-compliance is not a risk (in this context)
The minimum contents of the Technical Documentation
A general description of the product, including
(i) Photographs or illustrations showing external features, markings, and internal layout
(ii) Versions of software or firmware which can affect the compliance with a Directive’s Essential Requirements
(iii) User information and installation instructions
Conceptual design, manufacturing drawings, schemes of components including sub-assemblies, circuits, and other relevant similar elements. Descriptions and explanations necessary for the understanding of those drawings and schemes and understanding the operation of the product
A copy of the single EU Declaration of Conformity (DoC) for all relevant Directives
The results of design calculations made, examinations carried out, and other relevant similar activities
Test reports (whether generated internally or externally)
A list of the harmonised standards applied in full or in part. This should Reference of which have been published in the Official Journal of the European Union (OJEU) and when harmonised standards were partly applied, specify the parts which were applied
Where relevant harmonised standards or parts of them were not applied, descriptions of the solutions adopted to meet the relevant Essential Requirements including a list of any other relevant technical specifications applied.
Additional Technical Documentation requirements that can apply
“Internal Production Control” conformity assessment procedure (the simplest one, which doesn’t require any involvement by a Notified Body)
Other conformity assessment procedures will have additional requirements to this minimum list and certain Directives might as well (e.g. RED) so always verify with the relevant Directive to ensure that all the required Technical Documentation is completed.
Has its compliance continually maintained in manufacture. This can be achieved by a Quality Control Procedure that contains the necessary mission statements, procedures and work instructions to ensure that they maintain compliance with the Technical Documentation for all relevant Directives. This could also be achieved through 3rd-party assessment bodies.
Each product must have a single Declaration of Conformity (DoC) for all EU Directives
An example Declaration of Conformity (DoC) can be found on our dedicated CE EMC compliance testing page.
Some of the requirements that must be recorded in the DoC are as follows:
Products’ DoCs must be continuously updated and must be translated into the language or languages required by the Member States on whose markets the product is placed or made available.
Has the CE marking affixed, now specified by Reg. 765/2008/EU, this is unchanged from the previous CE mark:
CE Mark – legislative framework NLF
Each product must have a type, batch or serial number affixed, allowing identification of the product, including the manufacturer’s name, trade name or trademark, and a single postal address where they, or the Appointed Agent, may be contacted. This shall be done without misleading anyone about who is actually the manufacturer and all indelibly marked on the product itself. If indelibly marking the product is not possible for reasonable technical or economic conditions it can be marked on the packaging instead or as a very last resort on other documents accompanying the product.
Each product must be accompanied by a user manual or operating instructions with complete safety information for the product in a language that is easily understood by consumers and other end-users in the Member State in which the product is to be made available on the EU’s markets.
Note: The new LVD (2014/35/EU) and the RED (2014/53/EU) add more requirements than 768/2008.
The LVD (2014/35/EU) and the RED (2014/53/EU) both require the contact details marked on the product to be in a language easily understood by end-users and Market Surveillance Authorities.
The LVD (2014/35/EU) and the RED (2014/53/EU) both require the user instructions and safety information, as well as any labelling, to be clear, understandable and intelligible.
Authorised Representatives must have a written mandate that at least requires them to:
Act on the manufacturer’s behalf regarding all communications with Market Surveillance and National Authorities but this mandate cannot make them responsible for a product’s design, manufacture, assessment or the creation of its Technical Documentation.
Importers and Distributors must ensure, for each product they intend to make available on the EU market:
That the products manufacturer has carried out all conformity assessments, created the Technical Documentation and provided each product with a single DoC for all applicable Directives, and CE marking including the type, batch or serial number, manufacturer’s name, trade name or trademark, manufacturer’s single postal address for contact and clear/understandable operating instructions and safety information in a language that is easily understood by consumers and other end-users in the Member State in which the product is to be made available on the EU’s markets.
Importers and Distributors must also conform to the following:
Mark their name, trade name or trademark, and single postal address for contact on the product, or if not possible only for reasonable technical or economic conditions on the packaging or, in the last resort on other documents accompanying the product without misleading anyone about who is the actual manufacturer, agent, importer, etc is.
Ensure that any storage or transport they are responsible for does not jeopardise any products’ compliance with any relevant EU Directives. Mechanical shock and vibrations, and air pressure fluctuations during transportation could result in fractures in enclosures and could cause components and connections to fail and other environmental conditions such a temperature change could also put the products compliance at risk.
Be ready to provide any product’s documentation to Market Surveillance and National Authorities for up to 10 years after the last instance of the product was made available on the EU market in a language easily understood by the Authorities in that Member State.
Must, for trace-ability purposes, identify to Market Surveillance Authorities (upon their request) any economic operator who has supplied them with products and/or any economic operator they have supplied products to for up to 10 years after the supply.
Who consider / have reason to believe that a product is not in conformity with a Directive should not make it available on the EU market, recalling it if necessary, until it is brought into conformity.
Must immediately inform their national authorities if a product presents a risk EMI risk, radio-spectrum risk, EMF risk, safety risk, etc at least giving details of the non-compliance, and any corrective measures taken.
Who modify any products or even simply market any products (manufactured by someone else) under their own names (i.e. “re-badge” them) effectively becomes their manufacturers under EU law automatically taking on all of the manufacturer’s legal responsibilities for it, under all EU Directives so must comply with all points covered by points A – G.
Have direct legal rights under 768/2008/EU which they can enforce through national courts against both national authorities and against other Economic Operators for not respecting the requirements of 768/2008. If a product is non-compliant and requires corrective action, or presents a risk any/all of the Economic Operators in its supply chain can be held liable in law e.g. for damages.
Hopefully this article will have helped provide some of the questions you may have had about the New Legislative Framework (NLF) for CE marking. Fro more information on CE EMC testing please contact us and we will try our best to assist with your testing requirements.