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.
The two 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.
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 (in red in Table 1) and 10 Regulations (in blue in Table 1). 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 Regulation of Products
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.
- Directive 90/385/EEC Active Implantable Medical Devices
- Directive 92/42/EEC Hot-Water Boilers
- Directive 93/42/EEC Medical Devices
- Directive 98/79/EC In Vitro Diagnostic Medical Devices
- Directive 2000/14/EC Noise Emission in the Environment by Equipment for use Outdoors
- Directive 2004/52/EC Interoperability of Electronic Road Toll Systems
- Regulation (EC) No 552/2004 – Interoperability of the European Air Traffic Management Network
- Directive 2006/42/EC Machinery
- Directive 2007/46/EC Motor type approval
- Directive 2008/57/EC Interoperability of the Rail System within the Community (Recast)
- Directive 2009/48/EC Safety of Toys
- Directive 2010/35/EU Transportable Pressure Equipment
- Regulation (EU) No 305/2011 – Construction Products
- Directive 2013/29/EU Pyrotechnic Articles
- Directive 2013/53/EU Recreational Craft and Personal Watercraft
- Directive 2014/28/EU Explosives for Civil Uses
- Directive 2014/29/EU Simple Pressure Vessels
- Directive 2014/30/EU Electromagnetic Compatibility
- Directive 2014/31/EU Non-automatic Weighing Instruments
- Directive 2014/32/EU Measuring Instruments Directive
- Directive 2014/33/EU Lifts and Safety Components for Lifts
- Directive 2014/34/EU Equipment and Protective systems intended for use in Potentially Explosive Atmospheres (recast)
- Directive 2014/35/EU Electrical equipment designed for use within certain voltage limits
- Directive 2014/53/EU Radio Equipment
- Directive 2014/68/EU Pressure Equipment
- Directive 2014/90/EU Marine Equipment
- Regulation (EU) 2016/426 Appliances Burning Gaseous Fuels
- Regulation (EU) 2016/425 Personal Protective Equipment
- Regulation (EU) 2016/424 Cableway Installations
- Regulation (EU) 2016/797 on the Interoperability of the Rail System
- Regulation (EU) 2017/745 on Medical Devices
- Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices
- Regulation (EU) 2019/945 on Unmanned Aircraft Systems and on Third-Country Operators of Unmanned Aircraft Systems
- 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.
Manufacturers use agreed standards to show that their product meets the essential requirements of the regulation. The standards are European Standards (ENs) set by one of the European Standards Organisations (CEN, CENELEC or ETSI) on foot of a mandate from the EU Commission. Once the standard has been adopted by the EU Commission and published in the Official Journal of the EU is becomes a harmonised Standard (hEN). Any product that meets the requirement of the relevant hEN is presumed to conform to the essential requirements of the legislation.
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. Notified bodies are independent assessment bodies accredited by National Accreditation Bodies and listed by the EU Commission on the EU NANDO website. (see Notified Bodies below)
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.
A notified body is an independent organisation that is designated by an EU member state to assess the conformity of certain products before they can be placed on the EU market. 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 must be accredited by the National Accreditation Body in the Member State in which they are established. All NBs are listed on the EU NANDO website.
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 removes Technical Barriers to Trade, enables manufacturers to declare a high level of performance and allows products to be placed on the EU Single Market. In doing so it 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.
Impact of Brexit on product certification
EU product legislation will no longer apply in the UK when the transition period ends on 31 December 2020. This will have implications for businesses who use UK based notified bodies or accredited test facilities.
However, EU product legislation applies to products placed on the EU market irrespective of where they are manufactured which means that it will continue to apply to UK manufactured products placed on the EU market after end of the transition period. 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 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 will lose their status as EU Notified Bodies at the end of the transition period on 31 December 2020 and will be removed from the NANDO database. Certificates issued by UK based notified bodies will cease to be valid in the EU.
Manufacturers whose products have been certified by a UK notified body will have to transfer their certification to an EU based notified body before 31 December 2020 on the basis of a contractual arrangement between the manufacturer, the UK Notified Body, and the EU Notified Body.
Any manufacturer who does not transfer their certification will have to get their get their products recertified by an EU notified body after 1 January 2021.
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 will cease to be a national accreditation body within the meaning and for the purposes of Regulation No 765/2008 from the end of the transition period on 31 December 2020. As a consequence, its accreditation certificates will be no longer be considered as ‘accreditation’ within the meaning of Regulation No 765/2008 and will be no longer valid or recognised in the EU pursuant where Regulation No 765/2008 applies.
You can get further information on accreditation from the Irish National Accreditation Board website.
EU Blue Guide
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.