Directives
- Directives
- Verify requirements
- Need for notified body?
- Check conformity
- Technical documentation
- Affix CE marking
Directives
As a first step, you need to verify whether your product(s) fall(s) within the definition of an active implantable medical device in accordance with Article 1 paragraph 2a) to c) of Directive 90/385/EEC where also the term "active medical device" is defined. For a definition of "implantable device" see Annex IX, section I.1.2 of Directive 93/42/EEC on medical devices. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 6 is applicable. If all these conditions are fulfilled, Directive 90/385/EEC applies.
- Download Directive 90/385/EEC on Active Implantable Medical Devices
- For further information on the Directive 90/385/EEC on Active Implantable Medical Devices, please also visit the DG ENTR website dedicated to this subject by following this link: http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm
- For a further look at the harmonized standards for Active Implantable Medical Devices, please visit: http://ec.europa.eu/enterprise/sectors/healthcare/index_en.htm
Directives
If your product(s) fall(s) within the sector of appliances burning gaseous fuels, Directive 2009/142/EC (codified version) on appliances burning gaseous fuels (GAD) may apply to it.
- Download Gas Appliances Directive 2009/142/EC (GAD)

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_appliances_gaseous_fuels_en.pdf

- For further information on the Directive 2009/142/EC on appliances burning gaseous fuels (GAD), please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/gas_appliances/index_en.htm
Directives
If your product(s) fall(s) within the sector of cableway installations to carry persons the Directive 2000/9/EC applies.
- Download Directive 2000/9/EC on cableway installations designed to carry persons http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/cableways/index_en.htm
- For further information on the Directive 2000/9/EC on cableway installations, please also visit the DG ENTR website dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/mechanical/cableways/index_en.htm
- For a further look at the harmonized standards for Cableway installations to carry persons, please visit: http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/cableways/index_en.htm
Directives
If your product(s) fall(s) within the sector of energy-related products, it (they) might be subject to Directive 2009/125/EC on the Ecodesign of energy related products (the Ecodesign Directive):
- Download Directive 2009/125/EC on the Ecodesign of energy related products

- Download Factsheet Factsheet for the Ecodesign of energy related products

- For further information on Directive 2009/125/EC on Ecodesign, please also visit the DG ENTR website dedicated to this subject by following this link: http://ec.europa.eu/enterprise/policies/sustainable-business/ecodesign/index_en.htm
- For a further look at the harmonised standards for the Ecodesign of energy related products, please visit: http://ec.europa.eu/enterprise/policies/sustainable-business/documents/eco-design
Other Directives may additionally apply depending on specific products.
Directives
The EMC Directive 2004/108/EC applies to a vast range of equipment encompassing electrical and electronic appliances, systems and installations.
- Download Directive 2004/108/EC on Electromagnetic compatibility

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_electromagnetic_compatibility_en.pdf

- For further information on the EMC Directive 2004/108/EC please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/electrical/emc/index_en.htm
- For a further look at the harmonized standards for electromagnetic compatibility please visit: http://ec.europa.eu/enterprise/sectors/electrical/documents/emc/legislation/
Other Directives may additionally apply depending on specific products.
Directives
If your product(s) fall(s) within the sector “Equipment and protective systems for potentially explosive atmospheres (ATEX)" the following Directive applies:
- Download ATEX Directive 94/9/EC on Equipment and protective systems intended for use in potentially explosive atmospheres: http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/atex
- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_equipment_protective_systems_en.pdf

- For further information on the ATEX Directive 94/9/EC on Equipment and protective systems please visit the DG ENTR website dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/mechanical/atex/index_en.htm
- For a further look at the harmonised standards for ATEX, please visit: http://ec.europa.eu/enterprise/sectors/mechanical/documents/standardization/atex/index_en.htm
Directives
If your product(s) fall(s) within the product group of explosives for civil use, Directive 93/15/EEC applies.
- Download Directive 93/15/EEC on explosives for civil use
- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_explosives_for_civil_use_en.pdf

- For further information on Directive 93/15/EEC on explosives for civil use, please also visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/chemicals/specific-chemicals/index_en.htm
- For a further look at the harmonised standards for explosives for civil use, please visit: http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/explosives/
Directives
If your product(s) fall(s) within the product group of hot water boilers, Directive 92/42/EEC applies.
- Download Directive 92/42/EEC on hot water boilers

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_hotwater_en.pdf

- For further information on Directive 92/42/EEC on hot water boilers, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/pressure-equipment/index_en.htm
- For a further look at the harmonised standards for hot water boilers, please visit: http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/hot-water-boilers/index_en.htm
Directives
As a first step, you need to verify whether your product(s) fall(s) within the definition of an in vitro diagnostic medical device (IVD) in accordance with Article 1 paragraphs 2a), 2b) and 2c) of Directive 98/79/EC. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 5 are applicable. If all these conditions are fulfilled, Directive 98/79/EC applies.
- Download Directive 98/79/EC on in vitro diagnostic medical devices
- For further information on in vitro diagnostic medical devices, please also visit the DG ENTR website dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm
- For a closer look at the list of harmonised standards, please visit http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/iv-diagnostic-medical-devices/index_en.htm
Directives
If your product(s) fall(s) within the sector related to lifts, the following Directive applies.
- Download Directive 95/16/EC on Lifts
- For further information on Directive 95/16/EC on Lifts, please also visit the DG ENTR website dedicated to this subject by following this link: http://ec.europa.eu/enterprise/sectors/mechanical/personal-protective-equipment/index_en.htm
- For a further look at the harmonised standards for lifts, please visit: http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/lifts/index_en.htm
Directives
If your product(s) fall(s) within the sector of low voltage devices, Directive 2006/95/EC applies.
- Download Directive 2006/95/EC on Low Voltage Devices

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_low-voltage_en.pdf

- For further information on low voltage devices, please also visit the DG ENTR website dedicated to this subject by following this link: http://ec.europa.eu/enterprise/sectors/electrical/lvd/
- For a further look at guidance measures for low voltage devices, please visit: http://ec.europa.eu/enterprise/sectors/electrical/documents/lvd/guidance/
Other Directives may additionally apply depending on specific products.
Directives
If your product(s) fall(s) within the sector Machinery, the Directive 2006/42/EC on Machinery applies:
Directives
If your product(s) fall(s) within the measuring instruments sector Directive 2004/22/EC applies.
- Download Directive 2004/22/EC on measuring instruments

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_measuring_instruments_en.pdf

- For further information on Directive 2004/22/EC on measuring instruments, please also visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/measuring-instruments/index_en.htm
- For a further look at the guidance documents for measuring instruments, please visit: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/documents/guidance-documents/index_en.htm
Directives
As a first step, you need to verify whether your product(s) fall(s) within the definition of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active implantable medical device (Directive 90/385/EEC) or of an in vitro diagnostic medical device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article of Directive 93/42/EEC is applicable. If all these conditions are fulfilled, Directive 93/42/EEC applies.
- Download Directive 93/42/EEC on Medical devices (MDD)

- For further information on Directive 93/42/EEC on Medical devices (MDD), please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm
- For a further look at the guidance for medical devices, please visit: http://ec.europa.eu/enterprise/sectors/medical-devices/regulatory-framework/index_en.htm
Directives
If your product(s) fall(s) within the sector of construction or gardening equipment, it might be subject to the Directive 2000/14/EC on Noise Emission in the Environment.
- Download Directive 2000/14/EC on Noise emission in the environment

- For further information on Directive 2000/14/EC on Noise emission, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/mechanical/noise-outdoor-equipment/index_en.htm
- For a further look at the guidance for noise emission standards in the environment, please visit: http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/noise-emissions/index_en.htm
Other Directives may additionally apply depending on specific products.
Directives
If your product(s) fall(s) within the sector of Non-automatic weighing instruments Directive 2009/23/EC applies.
- Download Directive 2009/23/EC on Non-automatic weighing instruments

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_non_automatic_instruments_en.pdf

- For further information on the Directive 2009/23/EC on Non-automatic weighing instruments, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/measuring-instruments/index_en.htm
- For a further look at the guidance for measuring instruments, please visit: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/documents/guidance-documents/index_en.htm
Directives
If your product(s) fall(s) within the sector of personal protective equipment Directive on Personal Protective Equipment (PPE) 89/686/EEC applies.
- Download Directive on personal protective equipment (PPE)

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_personal_protective_equipment_en.pdf

- For further information on personal protective equipment, please also visit the DG ENTR website dedicated to this subject by following this link: http://ec.europa.eu/enterprise/sectors/mechanical/personal-protective-equipment/
- For more information about PPE, download the guidelines : http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/personal-protective-equipment/index_en.htm
Directives
If your product(s) fall(s) within the sector of Pressure equipment, Directive 97/23/EC applies.
- Download Directive 97/23/EC on Pressure equipment http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.htm
- For further information on the Directive 97/23/EC on Pressure equipment, please visit the DG Enterprise and Industry webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/pressure-equipment/index_en.htm
- For further reference documents for pressure equipment, please visit: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/
Directives
If your product(s) fall(s) within the sector of pyrotechnics, it might be subject to the Directive 2007/23/EC on Pyrotechnic articles.
- Download Directive 2007/23/EC on Pyrotechnic articles

- For further information on Directive 2007/23/EC on Pyrotechnic articles, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/chemicals/specific-chemicals/index_en.htm and http://ec.europa.eu/enterprise/sectors/chemicals/specific-chemicals/pyrotechnic-articles/index_en.htm
Other Directives may additionally apply depending on specific products.
Directives
If your product(s) fall(s) within the sector of Radio equipment & telecommunications terminal equipment, in general the Directive 1999/5/EC on Radio and telecommunications terminal applies.
- Download Directive 1999/5/EC on Radio and telecommunications terminal
- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_radio-equipment_en.pdf

- For further information on Directive 1999/5/EC on Radio and telecommunications terminal equipment, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/rtte/index_en.htm
Directives
If your product(s) fall(s) within the sector of Recreational craft Directive 94/25/EC applies.
- Download Directive 94/25/EC on Recreational craft

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_recreational_craft_en.pdf

- For further information on Directive 94/25/EC on Recreational craft, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/maritime/recreational-craft/index_en.htm
- For a further look at harmonised standards for recreational craft please visit: http://ec.europa.eu/enterprise/sectors/maritime/documents/recreational-craft/
Directives
If your product(s) fall(s) within the Toys sector the following Directive (2009/48/EC) applies.
- Download the Directive (2009/48/EC) on the safety of toys

- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_toys_en.pdf

- For further information on the Directive (2009/48/EC) that relates to the safety of toys, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/toys/index_en.htm
- For further reference documents on the Directive (2009/48/EC) that relates to the safety of toys, please visit: http://ec.europa.eu/enterprise/sectors/toys/documents/directives/
Directives
If your product(s) fall(s) within the sector of simple pressure vessels Directive 2009/105/EC applies.
- Download Directive 2009/105/EC on simple pressure vessels http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/spvd/index_en.htm
- Download Factsheet http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/documents/ce_simple_pressure_vessels_en.pdf

- For further information on Directive 2009/105/EC on simple pressure vessels, please visit the DG ENTR webpage dedicated to this sector by following this link: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/pressure-equipment/index_en.htm
- For a further look at reference documents for the Directive 2009/105/EC on simple pressure vessels please go to: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/spvd/index_en.htm
























