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Wireless EU

A CE mark signifies that the product conforms to health, safety, and environmental protection requirements by EU and is only required for products covered in the CE marking directives.

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Some common CE marking directives that wireless products need to conform to are:

  • Radio Equipment Directive

  • Low Voltage Directive

  • Electromagnetic Compatibility (EMC) Directive

  • Restriction on Hazardous Substances (RoHS) Directive​

  • Ecodesign Directive

Radio Equipment Directive (RED replace R&TTE directive) 

  • ​Wireless products need to be approved according to RED and have a CE mark to be sold in EU countries).

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  • Radio equipment is defined as s an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radio determination.

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  • RED establishes a regulatory framework for placing radio equipment on the market. It ensures a single market for radio equipment by setting essential requirements for safety and health, electromagnetic compatibility, and the efficient use of the radio spectrum.

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  • It also provides the basis for further regulation governing some additional aspects. These include technical features for the protection of privacy, personal data and against fraud.

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  • Furthermore, additional aspects cover interoperability, access to emergency services, and compliance regarding the combination of radio equipment and software.

Low Voltage Directive (LVD)

  • The directive covers all electrical equipment and components designed for use with a voltage rating of between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current.

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  • It provides the essential (safety) requirements that electrical equipment and components covered by it must comply with.

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  • The LVD is a self-assessed directive and as such, does not require the involvement of a Notified Body.

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  • *For household appliances, lighting equipment and welding equipment the requirements for human exposure to EMF are covered under LVD.

Electromagnetic Compatibility (EMC) directive

  • Covers products or components liable to generate electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.

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  • The directive aims to ensure that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance. It does this by:

    1. ​Limiting electromagnetic emissions from equipment in order to ensure that, when used as intended, such equipment does not disturb radio and telecommunication, as well as other equipment.

    2. The EMC directive also governs the immunity of such equipment to interference and seeks to ensure that this equipment is not disturbed by radio emissions, when used as intended.

Restriction on Hazardous Substances (RoHS) Directive

  • Aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste.

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  • It does this by restricting the use of certain hazardous substances in electrical and electronic equipment (EEE) that can be substituted by safer alternatives.

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  • The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

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  • The Directive also promotes the recyclability of EEE.

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  • *In parallel, the WEEE directive (not a CE marking directive) promotes the collection and recycling of such equipment.

Ecodesign Directive

  • Establishes a framework under which manufacturers of energy-using products are obliged to reduce the energy consumption and other negative environmental impacts occurring throughout the product life cycle.

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  • *Complemented by the Energy Labelling Directive (not a CE marking directive).

For more information, contact us.

Wireless EU
Battery EU

Packaging EU

EU rules on packaging and packaging waste cover both packaging design and packaging waste management.​ They aim to deal with the increasing quantities of packaging waste, which cause environmental problems. They also aim to remove barriers in the internal market – caused by EU countries adopting different rules on packaging design. 

Packaging & Packaging Waste Directive

Aims to :

  • Harmonise national measures on packaging and the management of the packaging waste

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  • Provide a high level of environmental protection

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  • Ensure the good functioning of the internal market

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*The packaging and packaging waste directive is not a CE marketing directive.

Radiation EU

Regulations relating to Radiation in Europe

  • Council Directive 2013/59/EURATOM - lays down basic safety standards for protection against the dangers arising from exposure to ionizing radiation.

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  • Electromagnetic Fields (EMF) Directive - ensures the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents.

Chemicals EU

A CE mark signified that the product conforms to health, safety, and environmental protection requirements by EU and is only required for products covered in the CE marking directives.

​

Some common directives that chemicals need to conform to are:

  • Restriction on Hazardous Substances (RoHS) Directive​

  • REACH directive (Registration, Evaluation, Authorization, and Restriction of Chemicals)*

Restriction on Hazardous Substances (RoHS) Directive

  • Aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste.

​

  • It does this by restricting the use of certain hazardous substances in electrical and electronic equipment (EEE) that can be substituted by safer alternatives.

​

  • The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

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  • The Directive also promotes the recyclability of EEE.

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  • *In parallel, the WEEE directive (not a CE marking directive) promotes the collection and recycling of such equipment.

REACH Directive

  • ​Requires that all chemicals imported and produced in Europe must be registered, evaluated, authorized, and restricted by a set of comprehensive procedures to better and simpler identify the chemical composition to ensure environmental and human safety

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*REACH Directive is not a CE marking directive.

Medical Devices EU

Medical Devices in the EU are regulated by the Medical Device Regulation (MDR) that replaces both the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), coming into full application in May 2021, with a translational period for certain medical devices until May 2024. Medical devices must comply with the MDR in order to obtain a CE marking certification and be sold on the EU market.
Medical Device Regulation (MDR)

  • Revised the laws governing medical devices to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. The new regulation takes on a life-cycle approach to medical device regulation instead of the previous directives which are more focused on the pre-approval stage of medical device manufacturing.
     

  • For medical devices to be certified, a Quality Management System (QMS) must be implemented. Many companies use the ISO13485 in their QMS implementation since it is the only QMS standard on the EU harmonized list.
     

  • More robust clinical evaluation will be conducted to strengthen pre-market approval of higher risk medical devices.
     

  • To improve the traceability of medical devices a unique device identification (UDI) shall also be implemented, and information on devices and studies being made public such as on the European Database for Medical Devices (EUDAMED).
     

  • In the new life-cycle approach, there will be requirements relating to post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices.

Scope & Definition of medical device

  • ‘Medical device’ is defined as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

    1. Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

    2. Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.

    3. Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.

    4. Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, products specifically intended for the cleaning, disinfection or sterilization of devices, and devices for the control or support of conception.

Medical device classification

  • The MDR has laid out 22 rules to determine the risk classification of medical devices into the following 4 groups:

    1. Class I: Lowest risk, non-sterile devices, or devices without a measurement function can be self-certified.

    2. Class I (Special Function): Low to medium risk, sterile devices, devices with a measurement function, invasive devices for transient use, or non-invasive devices that do not fit into other classes.

    3. Class IIa: Medium risk, invasive devices for short-term use.

    4. Class IIb: Medium to high risk, invasive devices for long-term use.

    5. Class III: Implantable devices for long-term use.

Brief Regulatory Process flow for Medical Devices to obtain a CE mark in Europe

  1. Appoint a "Person Responsible" for regulatory compliance

  2. Implement a Quality Management System (QMS) that includes Clinical Evaluation, Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plans

  3. Prepare a CE Technical File or Design Dossier (for Class III). The files should include the following not exhaustive items; information about the device, intended use, test reports, clinical evaluation report, risk management plan, IFU, labeling and Unique Device Identifier..

  4. Appoint a qualified handler of regulatory issues as an Authorized Representative based in the EU.

  5. QMS and Technical File or Design Dossier to be audited by a Notified Body.

  6. Upon successful completion of the Notified Body audit, as CE Marking certificate for the device and an ISO 13485 certificate for the manufacturing facility will be issued.

  7. After a Declaration of Conformity (DoC) is prepared that states the device is in compliance with the MDR, the CE Marking may be affixed.

  8. The device and its Unique Device Identifier (UDI) shall be registered on the EUDAMED database and the UDI to be on label.

  9. A Notified Body will carry out audits annually. Clinical Evaluation, PMS and PMCF activities shall be sustained to maintain the certification. 

Battery EU

A CE mark signifies that the product conforms to health, safety, and environmental protection requirements by EU and is only required for products covered in the CE marking directives.

​

Some common directives that battery products may need to conform to are:​

  • Batteries Directive

  • Low Voltage Directive

  • Ecodesign Directive

  • Restriction on Hazardous Substances (RoHS) Directive

Batteries Directive

Primary objective of the directive is to minimize the negative impact of batteries and waste batteries on the environment, while ensuring the smooth functioning of the internal market.

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  • To cut the amount of hazardous substances (in particular mercury, cadmium and lead) entering the environment, the directive laid down rules to:

    1. reduce the use of such substances in batteries. In particular, it prohibited the marketing of certain batteries with a mercury or cadmium content above a fixed threshold (0.0005 % by weight for mercury; and 0.002 % by weight for cadmium).

    2. ensure the proper management of waste batteries and also set targets for collection rates of disposed batteries and efficiencies of the recycling processes.​

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  • The directive also set out requirements for the labelling of batteries and their removability from equipment, and regarding information for end-users.

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  • *This directive is not a CE marking directive.

Low Voltage Directive (LVD)

  • The directive covers all electrical equipment and components designed for use with a voltage rating of between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current.

​

  • It provides the essential (safety) requirements that electrical equipment and components covered by it must comply with.

​

  • The LVD is a self-assessed directive and as such, does not require the involvement of a Notified Body.

​

  • *For household appliances, lighting equipment and welding equipment the requirements for human exposure to EMF are covered under LVD.

Ecodesign Directive

  • Establishes a framework under which manufacturers of energy-using products are obliged to reduce the energy consumption and other negative environmental impacts occurring throughout the product life cycle.

​

  • *Complemented by the Energy Labelling Directive (not a CE marking directive).

Restriction on Hazardous Substances (RoHS) Directive

  • Aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste.

​

  • It does this by restricting the use of certain hazardous substances in electrical and electronic equipment (EEE) that can be substituted by safer alternatives.

​

  • The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

​

  • The Directive also promotes the recyclability of EEE.

​

  • *In parallel, the WEEE directive (not a CE marking directive) promotes the collection and recycling of such equipment.

Packaging EU
Radiation EU
Chemicals EU
Medical Devices EU
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