1. 8/21/20151 Neoteric Enterprises Inc. European Certification The CE Mark

2. 2 A Synopsis As a prerequisite to participating in the global marketplace, all machinery manufacturers and end-users must consider safety and control reliability when designing their equipment.

3. 8/21/20153 A Synopsis One significant force behind this international safety effort is the 1995 European law requiring all machinery built for use in the European Union (EU) and European Economic Area (EEA) to comply with the Machinery Directive on safety.

4. 8/21/20154 A Synopsis The law mandates that machine builders indicate compliance by placing CE marking on their machinery.

5. 8/21/20155 A Synopsis Currently, there are 27 member countries in the EU and 3 countries (in addition to these 27) that are members of the EEA only.

6. 68/21/2015 A Synopsis EU AustriaItaly BelgiumLatvia BulgariaLithuania CyprusLuxembourg Czech R.Malta DenmarkThe Netherlands EstoniaPoland FinlandPortugal FranceRomania GermanySlovakia GreeceSlovenia HungarySpain IrelandSweden United Kingdom EEAIcelandLiechtensteinNorway

7. 8/21/20157 The CE Mark “CE” stands for “Communautees Europeenes” (French for European Community) and the CE Mark deals with the technical standardization of a broad range of manufactured products.

8. 8/21/20158 The CE Mark The goal is to reduce technical trade barriers and increase technical harmonization between member countries of the European Community. All products that fall under certain areas of manufacture governed by the CE Mark – whether manufactured inside or outside the European Community – must observe specific criteria if they are to bear the CE Mark and, consequently, be sold throughout the EU or the EEA.

9. 8/21/20159 The CE Mark From a ‘Certification’ standpoint, implications such as harmonization guidelines to define basic safety/performance requirements for products to be distributed in the EC, and technical specifications governing the manufacture and marketing of products that meet these requirements, are imperative for designers and manufacturers to consider.

10. 8/21/201510 The CE Mark Everything established as binding in the European rules and regulations has priority over national legislation. A Member State may never act contrary to a European regulation, directive or decision.

11. 8/21/201511 The CE Mark The application of European Standards (EN, IEC, CENELEC, etc.) is initially voluntary, (but legally binding if the manufacturer claims “CE” standards for its products), unlike the requirements of the directives, which indeed constitute a legal obligation.

12. 8/21/201512 The CE Mark A directive in the European Community is a European law that is legally binding for every Member State and which is above the laws of the individual Member States. A directive is not aimed directly at the citizens or companies in that Member State. However, products which are manufactured to harmonized European (CE) standards will be assumed to conform to the basic requirements concerning the health and safety of workers, consumers and the environment.

13. 8/21/201513 The CE Mark Applying the CE Mark to a manufactured product indicates that it satisfies the safety/performance requirements as specified by the EC guidelines, and that the manufacturer has carried out the conformity assessment procedures necessary to satisfy these guidelines. It is not, however, a quality assurance guarantee, but simply an administrative procedure to inform the inspection authorities of proof of conformity.

14. 148/21/2015 The CE Mark Steps to compliance: Assess the machinery for compliance to all applicable essential requirements Choose prescribed conformity assessment module Choose applicable European standards and test methods (where applicable) Prepare a ‘Technical Construction File’ (a compilation of all relevant documentation needed to demonstrate how and why the product complies with relevant directives) Prepare a ‘Declaration Of Conformity’ (a formal signed statement indicating conformity of the referenced machinery to the listed provisions of the applicable directive(s) and related standards) Write the Declaration Of Conformity and the Technical Construction File in one official language of the European Community Affix the CE Mark in accordance with the directive requirements

15. 158/21/2015 The CE Mark Methods of conformity – “Modules” Module A – Inspection and certification by the importer Module B – Inspection by a Notified Body Module C – Conformity to the type Module D – Production quality assurance (process) Module E – Product quality assurance (product) Module F – Product verification Module G – Unit verification Module H – Full quality assurance (according to EN 29001)

16. 8/21/201516 The CE Mark The first module “Module A” is intended for products with a low risk (as determined by a listing in Annex IV – Hazardous Machines, in the Safety of Machinery directive). This method may be conducted on behalf of the importer himself, and this is known as self- certification. The importer draws up the EC declaration Of Conformity and accompanying Technical Construction File himself and is obliged to keep available this documentation for the national authorities for at least ten years after the production of the final product.

17. 8/21/201517 The CE Mark In other words, if there are appropriate harmonized European standards (CENELEC – European Committee for Electro-technical Standardization), the manufacturer may self- declare and self-certify conformity as long as they use these standards. Module A is the prescribed conformity assessment procedure in this case.

18. 8/21/201518 The CE Mark If manufacturers choose not to use harmonized standards, or, if no harmonized standards are available for the machine to demonstrate compliance, they must attain a level of safety at least equivalent to that established by the harmonized standards through conformity to other national (CSA, UL, VDE, BSI, SEMKO, KEMA, etc.) or international standards (ISO or IEC).

19. 8/21/201519 The CE Mark Since these other standards do not give the presumption of conformity, however, the manufacturer will need to state in the Technical Construction File how the hazard was minimized or eliminated and refer to material used to develop the technical solution. Then, Module A once again becomes the prescribed conformity assessment procedure for this scenario.

20. 8/21/201520 The Directives There are a myriad of directives covering many products and machinery, however, for most machinery there are three common directives that encompass every aspect of the safety/performance requirements. They are the Safety Of Machinery (98/37/EC), Electromagnetic Compatibility (2004/108/EC), and the Low Voltage (73/23/EEC) directives.

21. 8/21/201521 The Directives The Safety of Machinery directive is (for most machinery) the main one for compliance. It lays down essential health and safety requirements for machinery users and people in the surrounding area. As mentioned, it includes an Annex (Annex IV) outlining what is considered to be hazardous machinery. If your machinery does not appear in this listing, self-declaration and self-certification (under Module A) applies.

22. 8/21/201522 The Directives A machine not mentioned in Annex IV but presenting equivalent risks is not subject to EU type-examination by a notified body (an independent testing laboratory that a member state has determined to be qualified to perform testing and certification functions related to specific EU directives). If a manufacturer has doubts as to its own risk analysis of non-Annex IV machines (through ‘due-diligence’), a notified body or other testing laboratory may confirm it. However, the directive does not impose any obligation to do so.

23. 8/21/201523 The Directives The Electromagnetic Compatibility (EMC) directive applies to apparatus, system, equipment, and installations containing electrical or electronic components insofar as this apparatus is liable to cause electromagnetic disturbance or the performance of the apparatus is liable to be affected by such disturbance. This includes all products that make use of electrical energy, including battery supplied products.

24. 8/21/201524 The Directives According to the essential protection requirements outlined in Annex I of the EMC directive, the apparatus shall be constructed so that the: Electromagnetic disturbance generated does not reach a level that prevents radio and telecommunications equipment and other apparatus from operating as intended Apparatus has an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as intended Intrinsic immunity is adequate to be weighed by considering: The level of performance reasonably expected of the apparatus The level of performance reasonably expected of the apparatus Specifications for an acceptable level of degradation of performance provided by the manufacturer to the end user Specifications for an acceptable level of degradation of performance provided by the manufacturer to the end user The consequences of degradation of performance The consequences of degradation of performance

25. 8/21/201525 The Directives The Low Voltage directive; for the purposes of this directive, “electrical equipment” means any equipment designed for use with a voltage rating of between 50 and 1,000 volts AC and between 75 and 1,500 volts DC, other than the equipment and phenomena listed as outside the scope of the directive.

26. 268/21/2015 The Directives Equipment and phenomena outside the scope of the directive (Annex II): Electrical equipment for use in an explosive atmosphere Electrical equipment for radiology and medical purposes Electrical parts for goods and passenger lifts Electricity meters Plugs and socket outlets for domestic use Electric fence controllers Radio-electrical interference Specialized electrical equipment for use on ships, aircraft, or railways