meeting the mark: understanding ce mark requirements

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Meeting the Mark: Understanding CE Mark Requirements

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Today’s Presenter

Travis MillerAssent ComplianceGeneral Counsel

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Agenda

Scope of CE Mark

The Blue Guide

Technical Files

Declarations of Conformity

Sanctions and Enforcement

Questions

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Assent ComplianceINTRODUCTION







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CE Mark Directive







What is Conformité Européenne (CE) Marking?

⬥ CE marking is a mandatory conformity mark for certain products sold within the European Economic Area (EEA).

⬥ The CE mark is found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.

⬥ CE marking is a manufacturer's declaration that the product meets the requirements of all applicable EC directives.

⬥ The mark consists of the CE logo and, if applicable, the four-digit identification number of the Notified Body involved in the conformity assessment procedure.

⬥ The CE mark states to European customs that a product meets the product compliance standards required for EEA market access.







CE Marking: Key Point

⬥ By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.

⬥ There are two key benefits CE marking brings to businesses and consumers within the EEA:⬦ Businesses know that products bearing the CE mark should be tradable in the

EEA without restrictions.⬦ Consumers enjoy the same level of health, safety and environmental protection

throughout the entire EEA.







CE Marking: Action Items

⬥ It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity and affix the CE marking to a product.

⬥ Manufacturers must follow these six steps to affix a CE marking:⬦ Identify the applicable directive(s) and harmonized standards⬦ Verify product specific requirements⬦ Identify whether an independent conformity assessment (by a Notified Body) is

necessary⬦ Test the product and check its conformity⬦ Draw up and keep available the required technical documentation⬦ Affix the CE mark and draw up the EU Declaration of Conformity







CE Marking: A Value Proposition

⬥ At first blush, this seems like a lot of work to put a label on one’s products.

⬥ However, remember it used to be a lot more work…

⬦ Before the CE Mark “Single Market” rules took effect, you had to demonstrate compliance with each European countries’ product regime

⬦ There was also a trend toward an increasing number of labels and marks that had to be affixed to a product, along with numerous certification bodies and standards







CE Marking: A Value Proposition⬥ Answer: Essentially, it is a lot less work to manage one set of rules, with the

trade-off of gaining access to all of Europe.⬥ However, there is a trade-off. If you are in one of these product classes, you are

in scope of CE, and a failure to comply bans your product from all of Europe.Active implantable medical devices (Directive 90/385/EEC)

EMC Directive (2014/30/EU) Lifts Directive (2014/33/EU) Noise emission in the environment (Directive 2000/14/EC)

Radio Equipment (Directive 2014/53/EU)

Appliances burning gaseous fuels (Directive 2009/142/EC)

Equipment and protective systems for potentially explosive atmospheres (Directive 2014/34/EU)

Low voltage electrical equipment (Directive 2014/35/EU)

Non-automatic weighing instruments (Directive 2014/31/EU)

Recreational craft (Directive 2013/53/EU)

Cableway installations to carry persons (Directive 2000/9/EC)

Explosives for civil use (Directive 2014/28/EU)

Machinery (Directive 2006/42/EC)

Personal Protective Equipment (PPE) (Directive 89/686/EEC)

Restriction of Hazardous Substances in Electrical and Electronic Equipment (Directive 2011/65/EU)

Construction products regulation (Regulation (EU) No 305/2011)

Hot water boilers (Directive 92/42/EEC)

Measuring instruments sector (Directive 2014/32/EU)

Pressure equipment (Directive 2014/68/EU)

Toys (Directive 2009/48/EC)

Ecodesign of energy related products (Directive 2009/125/EC)

In vitro diagnostic medical device (Directive 98/79/EC)

Medical devices (93/42/EEC)

Pyrotechnics (Directive 2013/29/EU)

Simple pressure vessels (Directive 2014/29/EU)







CE Marking: Details⬥ Products lawfully manufactured or marketed in one Member State should

in principle move freely throughout the EEA where such products meet equivalent levels of protection.

⬥ However, in the absence of Union harmonization legislation, Member States are free to legislate on their territory subject to the Treaty rules on free movement of goods (Arts 34-36 TFEU).

⬥ Barriers to free movement which result from differences in national legislation may only be accepted if national measures:⬦ are necessary to satisfy mandatory requirements (such as health,

safety, consumer protection and environmental protection),⬦ serve a legitimate purpose which justifies overriding the principle of

free movement of goods, and⬦ can be justified with regard to the legitimate purpose and are

proportionate with the aims.







CE Marking: Assuming You Are In Scope⬥ There are a regimented series of compliance assessments and

documentation collection requirements that need to be undertaken.⬥ Fortunately, there are a number of resources at your disposal.







The Blue Guide







The most relied upon guidance is the Blue Guide

What is the Blue Guide?

⬥ The Blue Guide is an instructional document outlining the effect of the New Legislative Framework (NLF) on product regulations.

⬥ The purpose of the Blue Guide is to describe how the product legislation fit together.

⬥ The Blue Guide is used to create a cohesive implementation of the regulatory regimes required to effectively populate a manufacturer's technical file.







The most widely used is the Blue Guide

How do you use this document?

⬥ The Blue Guide is a big complex document, but it is one of the only documents that addresses the CE Marking obligations holistically.

⬥ Section 1.2.3 is the base introduction regarding what the NLF is and how if functions together.◇ Sections 1.3 to 1.4 outline the liability functions and statute of limitations for all

products placed on the market via what are known as Basic Directives (Directives that apply to all products)

⬥ -17 specifically cover the scope of the Guide.








Understanding when you become liable

⬥ Liability incurs the moment a product is “placed on the market” in the EU.

⬥ A product is placed on the market when it is made available for the first time on the Union market.

⬥ Products made available on the market must comply with the applicable Union harmonization legislation at the moment they are placed on the market.








The Chain of Responsibility

⬥ The manufacturer has ultimate responsibility for the conformity of the product to the applicable Union harmonization legislation.

⬥ Responsibility applies whether he designed and manufactured the product himself or because the product is placed on the market under his name or trademark.

⬥ The manufacturer is responsible for designing and manufacturing the product in accordance with legal requirements of the relevant legislation and for carrying out the conformity assessment.








Section 3.1 Summarizes Manufacturers Obligations1. Carry out the applicable conformity assessment2. Draw up the technical documents3. Create an EU Declaration of Conformity4. Include instruction and safety information with the product5. Maintain lot traceable records, technical documents and safety

information for 10 years after product is placed on the market6. Affix the CE and other conformity marks to the product, as applicable7. Ensure procedures are in place to guarantee continued conformity8. Certify relevant products and quality systems








The Liabilities⬥ If you are not in conformance, you

are required to◇ take the necessary actions to bring the

product into conformity;◇ withdraw or recall the product, as

appropriate

⬥ If the product creates a EHS risk, you are required to◇ Inform the competent national authority








Section 3.3 Summarizes Importers Obligations

1. Ensure the conformity assessment has been carried out2. Ensure technical documents are available and the CE Mark and

appropriate markings are on the product3. Provide identifying information and contact details on the imported

product4. Maintain the product in a safe non-damaging fashion while in their

care5. Keep the declaration of conformity records for 10 years after import,

unless otherwise specified in the legislation6. Provide records on demand to the competent national authority7. Keep records of parties whom have been sold products for 10 years

after the product was supplied








Section 3.4 Summarizes Distributors Obligations

1. Distributors need to know what products must bear the CE Mark and maintain the appropriate records for the product at the time the product is placed on the market.

2. Ensure the manufacturer and importer contact details and traceability data are on the product.

3. Initiate corrective measures and cooperate with competent authorities.







Technical Files







Building a Technical File

Technical Files Are Your Records

◆ Technical files are a set of documents that describes a product and can prove that the product was designed according to the requirements of a quality management system.

◆ For EU shipments, technical files should contain the information required to show that the product properly complies with the requirements of the CE directives that apply to it.







Building a Technical File

Technical Files Core RequirementsAs a general guide, the following items should be included:⬥ Description of the apparatus, usually accompanied by block diagram⬥ Wiring and circuit diagrams⬥ General Arrangement drawing⬥ List of standards applied⬥ Records of risk assessments and assessments to standards⬥ Description of control philosophy/logic⬥ Datasheets for critical sub-assemblies⬥ Part list⬥ Copies of any markings and labels⬥ Copy of instructions (user, maintenance, installation)⬥ Test reports⬥ Quality control & commissioning procedures⬥ Declaration of Conformity







Building a Technical FileHarmonized Standards Are the Building Blocks◆ Harmonized standards are European standards to which Regulation

(EU) No 1025/2012 and sectoral Union harmonization legislation give a special meaning.

◆ Harmonized standards must be transposed at the nationallevel by the national standardization bodies. ◇ This transposition means that the European standards in question must be made

available as national standards in an identical way, and ◇ that all conflicting national standards must be withdrawn in a given period.

◆ A harmonized standard does not necessarily have to cover all “essential requirements” but it must be always clear which requirements are aimed to be covered.◇ These covered requirements are given a “presumption of conformity.”







Building a Technical FileWorkflow







Building a Technical FileConformity Assessment







Building a Technical FileTraceability Is the Critical Component◆ From a regulator's perspective, traceability matters

because it enables effective enforcement through market surveillancevia corrective measures including withdrawals and recalls.

◆ Union harmonisation legislation requires the traceability of products made available on the market, without stipulating how to achieve or implement these requirements.

◆ This means that the database technology or methodology implemented is up to you; however, you will be measured by its effectiveness.








When you have to use the CE Mark to declare◆ Not all products have to be CE marked. The obligation to affix the CE

marking extends to all products within the scope of legislative acts providing for its affixing, which are intended for the EEA.

◆ The CE marking must be affixed:◇ to all newly-manufactured products that are subject to legislation

providing for CE marking, whether manufactured in the Member States or in third countries,

◇ to used and second-hand products imported from third countries that are subject to legislation providing for CE marking, and

◇ to modified products that, as new, are subject to legislation providing for CE marking and which have been modified in a way that could affect the safety or the compliance of the product with the applicable harmonization legislation.







Declarations of ConformityDrawing Up a Declaration of Conformity (DoC)◆ The manufacturer or the authorized representative established within the

Union must draw up and sign an EU Declaration ofConformity as part of the conformity assessment procedure.

◆ The EU Declaration of Conformity must contain all relevant information to identify:◇ the Union harmonization legislation it is issued against, ◇ the manufacturer and/or the authorized representative and/or notified body, ◇ the product, and◇ a reference to harmonized standards or other technical specifications.

◆ A single Declaration of Conformity is required whenever a product is covered by several pieces of legislation.

◆ The single declaration of conformity can be made up of a dossier containing all relevant Declarations of Conformity.








A Model Declaration of Conformity Contains1. A number identifying the product/family of products/lots etc…2. The name and address of the manufacturer/authorized rep3. Statement the declaration is issued under the responsibility of

the manufacturer4. Supplementary information for traceability5. Citation to all Union harmonized legislation6. Name and identity of the notified body, if applicable7. Any supplemental information8. Date of issue, signatory of an authorized representative, and title

of the endorser







Declarations of ConformityAffixing the CE Mark◆ The CE mark may not be affixed until the conformity assessment

procedure has been completed to ensure the product complies with all the provisions of the relevant Union harmonization legislation.

◆ This will usually be at the end of the production phase. This poses no problem if, for example, the CE marking is on a data plate that is not affixed to the product until after the final inspection.

◆ CE marking may not be affixed at any other stage of the production phase, until the conformity of the product is verified as part of the production process.







Declarations of ConformityWhere can I place my CE Mark?◆ The CE mark must be affixed visibly, legibly and indelibly to the product

or to its data plate.◆ The requirement for visibility means the CE mark must be easily

accessible for all parties. ◇ The CE mark may be affixed on the back or underside of a product. ◇ The requirement for visibility does not necessarily mean the CE marking must be visible

before opening a product’s packaging because affixing the CE marking also to the packaging is only necessary in case this is explicitly required in the relevant Union acts.

◇ A minimum height of 5 mm is required to ensure that it is legible. ■ However according to the several pieces of legislation (220) the minimum dimension of

the CE marking may be waived for small devices or components.◇ Regulation (EC) No 765/2008 and Decision No 768/2008/EC do not forbid any kind of design

(e.g. ‘hollow’ design) as long as the above conditions are respected. However, electronic labelling only is not allowed.








What does it look like?








Removing Competing Marks◆ The CE marking replaces all mandatory conformity markings having

the same meaning, which existed before harmonization took place.

◆ The affixing of additional markings (such as a protected trademark of a manufacturer or other private/national markings) is allowed to the extent that such markings do not create confusion with the CE marking.

◆ This means, get rid of these:







Sanctions and Enforcement







Sanctions

Catching the Bad Actors◆ Member States have to ensure the correct implementation of the

regime governing the CE marking and take appropriate action in the event of improper use of the marking.

◆ Member States have to also provide for penalties for infringements, which may include criminal sanctions for serious infringements.

◆ Member State must notify to the Commission and to the other Member States when it decides to restrict free movement due to incorrect affixing of the CE marking, or when it takes action against those who are responsible for a non-compliant product bearing the CE marking.







Sanctions

Catching the Bad Actors◆ It is up to the Member States to lay down and

implement the mechanism for enforcing the provisions of the Regulation in their territories.

◆ According to Article 41 of the Regulation, ‘the penalties provided for shall be effective, proportionate, and dissuasive and may be increased if the relevant economic operator has previously committed similar infringement’. ◇ Fines are the most typical methodology◇ Criminal prosecutions can occur for serious infractions







SanctionsSpeciality staff investigate in-country violations







Sanctions

In-Country Enforcement Takeaways◆ Once a product is in the European Union and displays the CE mark,

there is a presumption of conformity.

◆ As a result, the majority of prosecutions and investigations take place because of accidents or incidents.

◆ An investigation finds technical non-conformances in manufacturers' technical files substantially more often than any other violation.

◆ These technical file violations will create a presumption of violation and liability in relation to the incident.







SanctionsCustoms usually performs import screenings







SanctionsCustoms Enforcement Takeaways◆ Importers and non-EU based manufacturers have to contend with

customs authorities to enter the EU.

◆ There are two ways customs authorities can inspect a product◇ laboratory analysis◇ technical document inspection

◆ One costs money and takes several weeks, one is a cursory documentation review from a spot check

◆ The vast majority of customs violations and product withdrawals are a result of technical documentation gaps.







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