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Within the EU there is a comprehensive regulatory framework to operate effectively for the safety and compliance of industrial products to protect the various public interests and for the proper functioning of the single market. Products that conform to EU product legislation can be identified by the CE Mark.

What does the CE mark do?

A CE mark is a declaration by a manufacturer that the product meets the requirements of the relevant EU legislation.

It enables manufacturers to declare a high level of performance, allows products to be placed on the EU Single Market and enables the free movement of goods throughout the EU Single Market.

In order to apply a CE mark to a product, it must be tested and found to comply with the relevant EU legislation. The CE mark can only be applied to products where it is mandated by EU legislation and must not be applied to any other products.

The Marine Equipment Directive (Directive 2014/90/EU) mandates the application of the wheel mark and the Pressure Equipment Directive (Directive 2014/68/EU) mandates the use of the Pi mark instead of the CE mark.
 

EU Product Legislation

The key pieces of legislation are Regulation (EC) No 765/2008 on market surveillance and accreditation which established the legal basis for accreditation and market surveillance and consolidated the meaning of the CE marking and Decision No 768/2008/EC on a common framework for the marketing of products which updated, harmonised and consolidated the various technical instruments already used in EU harmonisation legislation, Regulation (EU) No 1025/2012 on European standardisation which updated the legal framework on European Standardisation, and Regulation (EU) 2019/1020 on market surveillance and compliance of products which updated the framework for market surveillance.

In addition, there are 34 different pieces of EU legislation covering different types of manufactured products ranging from construction products to pressure equipment. This consists of 24 Directives and 10 Regulations. Directives must be translated into national law before they come into effect whereas Regulations have direct effect, though some aspects of enforcement may require legislation to ensure they are compatible with national regulatory or legal systems.

EU product legislation applies to products placed on the EU market irrespective of where they are manufactured. This means that products manufactured in ‘third countries’ must comply with EU legislation if they are to be sold in the EU Single Market.

1 Directive 90/385/EEC Active Implantable Medical Devices
2 Directive 92/42/EEC Hot-Water Boilers
3 Directive 93/42/EEC Medical Devices
4 Directive 98/79/EC In Vitro Diagnostic Medical Devices
5 Directive 2000/14/EC Noise Emission in the Environment by Equipment for use Outdoors
6 Directive 2004/52/EC Interoperability of Electronic Road Toll Systems
7 Regulation (EC) No 552/2004 - Interoperability of the European Air Traffic Management Network
8 Directive 2006/42/EC Machinery
9 Directive 2007/46/EC Motor type approval
10 Directive 2008/57/EC Interoperability of the Rail System within the Community (Recast)
11 Directive 2009/48/EC Safety of Toys
12 Directive 2010/35/EU Transportable Pressure Equipment
13 Regulation (EU) No 305/2011 - Construction Products
14 Directive 2013/29/EU Pyrotechnic Articles
15 Directive 2013/53/EU Recreational Craft and Personal Watercraft
16 Directive 2014/28/EU Explosives for Civil Uses
17 Directive 2014/29/EU Simple Pressure Vessels
18 Directive 2014/30/EU Electromagnetic Compatibility
19 Directive 2014/31/EU Non-automatic Weighing Instruments
20 Directive 2014/32/EU Measuring Instruments Directive
21 Directive 2014/33/EU Lifts and Safety Components for Lifts
22 Directive 2014/34/EU Equipment and Protective systems intended for use in Potentially Explosive Atmospheres (recast)
23 Directive 2014/35/EU Electrical equipment designed for use within certain voltage limits
24 Directive 2014/53/EU Radio Equipment
25 Directive 2014/68/EU Pressure Equipment
26 Directive 2014/90/EU Marine Equipment
27 Regulation (EU) 2016/426 Appliances Burning Gaseous Fuels
28 Regulation (EU) 2016/425 Personal Protective Equipment
29 Regulation (EU) 2016/424 Cableway Installations
30 Regulation (EU) 2016/797 on the Interoperability of the Rail System
31 Regulation (EU) 2017/745 on Medical Devices
32 Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices
33 Regulation (EU) 2019/945 on Unmanned Aircraft Systems and on Third-Country Operators of Unmanned Aircraft Systems
34 Regulation (EU) 2019/1009 on EU Fertilising Products

 

How the System Works

The EU drafts legislation which sets out the basic requirements which must be met to place the product on the EU market. These requirements are generally there to stop the products injuring people or causing damage to property. It also sets out which testing modules must be used and whether the manufacturer is required to use a notified body to independently certify their products.

Some products which are subject to tighter regulation manufacturers are required to use a notified body to certify conformity of  their products to the relevant standards. EU legislation sets out a number of different modules that should be used in assessing the conformity of products and several modules require testing to be carried out and the product certified by a notified body. Notified bodies are independent assessment bodies accredited by National Accreditation Bodies  and listed by the EU Commission on the EU NANDO website.

Finally, the manufacturer compiles the technical file and makes the Declaration of Conformity that the product meets the requirements of the regulation and then applies the conformity mark the product. The conformity mark is normally the CE mark, though other marks are mandated for marine equipment and pressure vessels.
 

Impact of Brexit on product certification

EU product legislation will no longer applies in Great Britain (it continues to apply in Northern Ireland). This has implications for businesses who import products from Great Britain, or who used UK based notified bodies or accredited test facilities.
 

UK Products
EU product legislation applies to products placed on the EU market irrespective of where they are manufactured which means that it still applies to UK manufactured products placed on the EU market. All UK manufactured products will still need to:

  • Be marked with the CE mark
  • Be certified by an EU notified body where required by EU legislation
  • Have a valid and up to date EU Declaration of Performance
     

Notified Bodies
Notified Bodies must be established in a Member State and designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant EU product legislation.

UK Notified Bodies lost their status as EU Notified Bodies on 31 December 2020 and were removed from the NANDO database. Certificates issued by UK based notified bodies are no longer valid in the EU.

Manufacturers whose products have been certified by a UK notified body and who did not transfer their certification before 31 December 2020 have to get their get their products recertified by an EU notified body.
 

Accreditation and test certificates
Many Irish businesses use UK laboratories to use demonstrate product performance as meeting regulatory requirements. This applies both to manufacturers self-certifying their products and to manufacturers using a UK test result as part of a broader EU regulatory submission. 

The UK Accreditation Service ceased to be a national accreditation body within the meaning and for the purposes of Regulation No 765/2008 on 31 December 2020. As a consequence, its accreditation certificates are no longer considered as 'accreditation' within the meaning of Regulation No 765/2008 and are not valid or recognised in the EU where Regulation No 765/2008 applies.

You can get further information on accreditation from the Irish National Accreditation Board website.

The Blue Guide is a comprehensive guide to the operation of the EU single market for manufactured products. It is available on the EU Commission website.