ce certification lcd panel brands

CE Certification is a mandatory marking that indicates conformity in accordance with the legal and technical directives of the European Union (EU). CE has been in effect since 1993 and is not necessarily a marking of quality but the CE Certification is known as a ‘passport’ for EU-wide free flow for a wide range of industrial products.

The CE Mark certifies that a variety of products have met the relevant environmental, health and safety requirements of the European Union, and therefore ensures safety for consumers and the workplace.

In order for manufacturers to market their products in the EU and abroad, products must meet the relevant CE mark requirements. Once the CE mark has been approved, the products can be marketed within the EU without having to undertake further tests and modifications for each country.

Underwriters Laboratories does not necessarily approve products as opposed to evaluating materials, systems, components and products for the relevant compliance to the UL requirements. In order to carry a UL certification mark, the products must remain compliant with the standards set by UL.

UL and ULC ensures that companies supply safer products to the US, Canadian and global markets. The certification also improves the safety of products, as well as increases consumer confidence in their compliance and is regarded as a trusted symbol of safety.

RoHS (Restriction of Hazardous Substances) is an EU Directive that relates to electrical and electronic equipment placed on the European market. The RoHS Directive is closely linked with WEEE Care (the Waste Electrical and Electronic Equipment Directive), which controls the collection and recycling of electrical and electronic equipment in order to solve the problem of toxic waste.

RoHS aims at reducing hazardous substances being utilised in electrical and electronic equipment, while WEEE Care aims at reducing electrical and electronic equipment in products entering waste.

RoHS certification states that from 1 July 2006, electrical and electronic equipment that is put on the market cannot exceed maximum values of any of the following six substances.

The RoHS Directive applies to those who manufacture Electrical and Electronic Equipment (EEE), those who import these goods into the EU; those who export to other Member States; and those who re-brand equipment produced by others.

The primary aim of WEEE Care is to control the Waste of Electrical and Electronic Equipment and to recover and re-cycle such waste in order to reduce the volumes of electrical and electronic waste being disposed to landfill. WEEE Care arranges the collections and recovery of equipment to recycle in an environmentally friendly way. WEEE Care is a European environmental directive that aims to reduce the impact of disposing of electrical and electronic equipment in the environment.

The RoHS directive bans certain levels of substances being used in electrical and electronic equipment and WEEE Care aims at the correct disposal of this equipment.

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What are the criteria and procedure for CE marking of LCDs and which institutions can I contact? A liquid crystal display is a kind of flat panel display. It is used for the screen display of televisions and computers. The advantages of this display are low power consumption, small size, and low radiation. The LCD uses a liquid crystal solution in two polarized materials, so the current flowing through the liquid causes the crystals to rearrange themselves to achieve the purpose of the image. If you need to apply for CE certification, you can contact our company BEST ONE Inspection for the procedure.

CE marking provides a single technical specification for products from all countries for trade in the European market and simplifies trade procedures. In order to enter the European Union and the European Free Trade Area, products from all countries must be CE certified and have the CE mark on the product. CE marking is therefore the passport for products to enter the EU and EFTA markets.

CE certification means that the product meets the safety requirements set out in the EU Directive; it is a company’s commitment to consumers and increases their confidence in the product; products bearing the CE mark reduce the risk of being sold on the European market.

CE consists of EMC (Electromagnetic Compatibility) + LVD (Low Voltage Directive), EMC also includes EMI (interference) + EMC (anti-interference), LVD is also commonly known as SAFETY safety, general low voltage products AC less than 50V, DC less than 75V can not LVD project. Low voltage products only need to test EMC and issue CE-EMC certificate, high voltage products need to test EMC and LVD and issue two certificates and reports CE-EMCCE-LVD.

Safety design documents (including main design drawings, i.e. design drawings indicating creepage distance, clearance distance, number and thickness of insulation layers).

the certificate of registration of the product in the EU (for certain products, such as Class I medical devices, general IVD in vitro diagnostic devices).

EU laws, regulations, and harmonized standards are not only numerous but also very complex, so seeking the help of an EU notified body is a wise move to save time and effort and reduce risks.

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We have recently upgraded our product certification. We have conducted CE,FCC and ROHS certification for the latest certification standards for our Interactive LCD Digital Display and All in one kiosk and Stretched displays. The certification details as following:

A: All of our TFT LCDs meet or exceed 130 degree (Horizontal) and 110 degree (Vertical) viewing angle. Our wide view film technology achieve viewing angle 160 degree (Horizontal) and 140 degree(Vertical). We also have Super-Wide-View technology that will achieve 85/85/85/85 viewing angle, which is the best technology for viewing angle and color reproduction. Please consult the individual part specification for details.

A: NCM enables vivid reproduction of even the most subtle colors, such as pastels and flesh tones, and provides independent control of six colors without one color influencing any of the others. It supports 18-bit and 24-bit color and full motion video and compensates for any color shifts caused by LCD components such as CCFLs and optical films. Read the NCM Technology WhitePaper.

A: There are basically two approches to increase a display"s sunlight readability: increase the brightness level of the display, or reduce the ambient light reflection on the display surface. Good Display has several technology for outdoor readable applications, such as high brightness panel, transflective panel, anti-reflection and antiglare surface treatment, for more information, please check Outdoor Use TFT Displays for more information.

A: Yes. Good Display TFT LCDs response time is between 16ms to 25ms. Most of our newly developed LCD panels have 16ms response time, which is enough for moving picture. Please check the individual display specification for detail information.

A: LCD displays typically feature a wider viewing angle from straight on or above, compared to the viewing angle from below. The reverse-scan feature enables customers to select either a normal scan or reverse scan to obtain the best intended image, depending on whether the mounted display will be viewed typically from above or below. Good Display TFT LCDs have reverse scan function.

A: The defination of the CCFL lifetime is when the brightness level droped to 50% of its initial full brightness level. All the CCFL backlights for TFT LCDs are rated at 50,000 hours minimum. But most of the CCFL lamp unit can be replaced easily.

A: For industrial grade LED backlits TFT-LCD, the minimum lifetime is 60K hours. Be sure to consult the individual part specification for information on a specific LCM.

A: Many of the Good Display TFT LCDs operate at both 3.3 and 5V. However, as the 3.3V becomes the new standard, the LSI manufactory might decide to only support 3.3V, that is not controlled by Good Display. Please check the individual part specification for information.

A: The Mean time between failures (MTBF) data is not generally available. Under special circumstances MTBF data can be provided, but this is the exception, not the norm. Please contact your representative for further information.

A Machinery shall be CE Marked before it is placed on the market or put into service or use. Normally a Machinery has an Electrical Equipment made of one or more control panels and components “in the field”.

The Control panel is often engineered and manufactured by a different producer then the machinery itself and it falls under the Low Voltage Directive 2014/35/EU (if powered above 50Vac).

That was interpreted in the following way: Manufacturer P of the control Panel sells to Manufacturer M of the Machinery and is not obliged to CE Mark its product.

In other terms: manufacturer “P1” of a part of the control panel sells it to the final manufacturer “P2”, who assembles the product and sells it to “M”. P2 has to CE mark the product before it is transferred to “M”.

As for “making available”, the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.

Not all experts think that way.There is a school of thought that strasses the fact that there is no specific product standard for Industrial Control panels in Europe: therefore the product cannot be CE Marked. The only way to support that reasoning is to demostrate the ICP is not a product falling under the Low Voltage Directive, in other termsit is not an Electrical Equipment. Here the definition taken from the Guide to the LVD:

Electrical Equipment: item used for such purposes as generation, conversion, transmission, distribution or utilisation of electrical energy, such as machines, transformers, switchgear and controlgear, measuring instruments, protective devices, wiring material, current-using equipment.

Nobody argues a swichgear must be CE Market - it actually has a product standard: EN 61439-1. Than, what is the difference between a Distribution Panel and an Industrial Control Panel? An ICP is not an Electrical Equipment, falling under the LVD, because it does not have a specific product standard? We consider that reasoning "weak".

Let iCertifi help you with your CE approvals. Since we are a consulting firm, we offer a different approach to homologations.  Since we are not a test laboratory, we have partnerships with several test laboratories worldwide.  We will negotiate the pricing from multiple test labs to ensure you obtain the best pricing possible.  Since we are not tied to a single laboratory, we can also find laboratories with the best completion time. This allows you to obtain your certifications much faster which will allow your time to market to be expedited.

We have helped many companies become certified to sell their products in the European Union. Our experience in accordance with CE norms and our international partnerships with laboratories  and regulators allows you to engage a single company for all your International Market Access (IMA) needs.

Product manufacturers needed to display the CE mark(stamp) on their product. The process of getting a CE mark(stamp) may seem vague.  An outline of the process is as follows:

Distributors of products requiring CE marking should be inspected to ensure that this brand is present and properly positioned in the items. Distributors must also examine the accompanying documentation to ensure that the CE mark is obtained legally and correctly.

If you are a merchant for a product that is distributed in the European Economic Area, please contact us for professional certification services. We can help you to ensure that your products are on a legal level of safety, a level of health and environmental protection.

Postal stamps are established in accordance with the EC directives. This Directive is a legal act of the European Union (EU). The EU has established product codes for many industries in 1985. These standards are standards of health, safety and environmental protection.

Presently, set standards and legal standards are managed by two separate entities. While the European Union has established compliance with CE rules, you do not have to go through the EU. Instead, compliance can be applied in different ways.

1. Each distribution company has the opportunity to check the compliance efforts of their manufacturers. If the distributor checks their client’production, the manufacturer of the product must provide evidence of their CE mark.

iCertifi can assist you with  your CE certification which often is the first step in International Market Access.  If your ambitions are to sell your products globally, iCertifi can assist you with this process as well.  We are proficient in certifications such as; CE, FCC, Industry Canada (IC), safety type approval (CB Scheme, IRAM S-Mark), Energy Efficiency such as CONUEE in Mexico and more.  iCertifi can also provide you with local applicant services in any country you wish to penetrate.  Let us help you eliminate the burdens to International Market Access. Contact us at (541) 275-5020 to get started on your CE certification.

CE Certificate of Compliance allows products to move freely and sell on the European market. This brand offers consumers proof that the product meets the environment, health and safety standard set by the EEA. Performance requirements are not a guarantee of quality. This simply means that the product fulfills the conditions for sale in the EU.

It is important to note that the CE marking does not mean that the product is made in the EEA. The European conformity marking indicates that it has reviewed, approved and pass the environment, safety and health that the EEA has established for a product to be sold in the EEA.

The CE mark is a mandatory conformity mark on many products sold in the single market European Economic Area (EEA). The CE mark certifies that a product has met EU consumer safety, health, or environmental requirements.

By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 27 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.

The CE mark is a declaration by Hope Industrial that the product conforms with applicable requirements set out in EU law necessary before applying the mark. In order for an industrial monitor or related product to display the CE mark, Hope Industrial products have met some or all of the following Directives:EC-DirectiveSubjectDocument No.Low Voltage DirectiveProducts with a voltage rating of 50-1000 VAC or 75-1500 VDC2014/35/EU

Electromagnetic Compatibility (EMC) DirectiveApparatus liable to cause electromagnetic disturbance or which is liable to be affected by such disturbance2014/30/EU

More information on CE marking requirements is available directly from the European Commission, including "The Blue Guide," which provides detailed information.

RoHS Directive 2011/65/EU (Restriction of Hazardous Substances) is an included requirement for displaying a CE mark and restricts the use of some hazardous substances in electronics and electrical equipment sold in Europe. The Directive bans selling new products that contain more than specified levels of the following materials in the EU market: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants.

RoHS Directive 2015/863/EU amends the directive above and adds four additional substances, Bis(2-Ethylhexyl) phthalate (DEHP), Benzyl butyl phthalate (BBP), Dibutyl phthalate (DBP), Diisobutyl phthalate (DIBP).

RoHS-compliant parts must have less than or equal a maximum concentration of 0.1% (by weight) of lead, hexavalent chromium, mercury, PBB, PBDE, DEHP, BBP, DBP, DIBP and 0.01% for cadmium, unless the parts qualify for an exemption.

CE Certification stands for “European Conformity.” It is necessary for many products to be sold in the European Union. The CE Mark verifies that the products that are being sold in the EU have met all required safety, health, and environmental protection requirements. It is not just products that are made in the EU that have to have this certification, it is also products that are made in other countries and that are being sold in the European Union. CE certification symbolizes the CE that is primarily inserted on the backside of specific products sold in the (EU) European Union and the (EEA) European Economic Area.

CE Certification lets both consumers and regulators know that the particular product that is CE-Certified complies with the safety standards in the European Union. The safety standards were put in place to prevent people from experiencing injuries or health problems as a result of buying and using a product that was sold in the EU. It also helps to protect the environment because it requires manufacturers to comply with certain environmental standards as well.

For some products, it is required by law to have an independent assessment done by a notified body. If the notified body approves your company, then you will qualify for CE Certification. Once you have the CE Certification and after you pass all of our tests, then you will be able to display the CE mark on your products and sell them legally in the European Union.

Therefore, most products with CE marks indicate that the manufacturer of the product holds the onus and comply with all the legal requirements of safety, health, and environmental set aside by the European Union. CE mark refers to a compulsory European Union marking responsible for governing the products sold within the (EEA) European Economic Area.

The mark signals a declaration from the manufacture giving proof that the products are aligned with the New Approach Directives from the European Union. This regulation set not only applies to goods within the threshold of the European Union but also to those goods produced and prepared to be sold in the EEA. Therefore, the CE marking makes all products to be recognized in different countries that the products are under CE regulations.

Before any products that fall under these regulations are sold, a CE mark must be placed to make them accessible in the EU marketplace. Moreover, CE mark indicate the following on a product:The goods meet the pertinent requirements of the New approach directives of the EU.

Above the mentioned directives above, which are the most common for Electronic products, there are other directives such as Explosive, Medical Device, Lifting, Measurement & Control, and others. It’s the manufacturers with his supply chain responsibility, to verify the product meets all relevant requirements before putting a product in the market.

360Compliance provides regulatory  Testing & Certification services for hundreds of Hi-Tech manufacturers annually >  partial list:https://360compliance.co/customers/

When you have a CE certification, you are free to sell your products on the European Union market. However, before displaying your product on the EU market, you must be acquainted with what is a CE certification, the products that need a CE mark, and what the CE mark stands for when placed on a product.

The CE Marking Association (Wemtech Ltd) have been leading manufacturers through product compliance covering all aspects of product conformity. Take a look at some of our case studies to find out how we have helped some of our clients…

Staffordshire based TUFFA UK Limited is specialist manufacturer and supplier of storage tanks. A recent industry change had seen the majority of TUFFA’s competitors CE Mark their products, so with little product legislation knowledge, they turned to Wemtech for help.

T&E Display Group, are successful manufacturers of commercial interiors and bespoke point-of-sale display equipment. While T&E were confident in the safety of the products, they had to prove it, so their MD contacted the us for a third party opinion.

Harry West Ltd is a manufacturer of farm machinery. After a visit by the HSE they concluded Harry West Ltd needed to address some of their Product Safety and Legislation requirements. The CE Marking Association helped take them through the conformity process.

Since 1975, Middleton Engineering have been involved with designing and manufacturing industrial waste processing machinery.  They needed to confirm that they are meeting the correct and current product conformity requirements to ensure it is safe for use.

Without any prior experience of performing an FMEA, Focal Earth (a specialist in rail logistic solution) turned to MAS West Midlands and the CE Marking Association for help to produce an FMEA and a test plan to enable a robust design to be developed.

Dingley Dell Enterprises developed a new wood burning pizza oven, for use in a commercial environment and wanted to know what legislation would be applicable. We carried out an investigation to help clarify and provide information on their concerns.

Ansa Door Systems is a door system manufacturer and as a result of working with us Ansa Door Systems have received guidance on product compliance and associated Standards saying “We are extremely pleased with the assistance we have received.”

We Build It Ltd design and manufacture a range of sewerage treatment plans. They were looking to begin exporting their products. To do this We Build It needed to CE mark their wastewater treatment systems under the Construction Products Directive.

Gainsborough Baths have been designing and manufacturing high quality power assisted baths for the care sector for over 20 years when the company were asked to bring their CE Marking requirements in line with current legislation by a local Trading Standards Officer.

Willenhall based BEWO required CE Marking support for their specialist tube cutting machines. Getting in touch through MAS-WM we were able to provide an intensive workshop and give practical advice on the CE mark and the issues surrounding it.

The CE mark indicates that a product is compliant with all applicable directives and regulations – which in turn requires the CE mark. Such ‘CE marking directives’ and regulations apply to a wide range of products, including electronics, toys, helmets, sunglasses, and medical devices.

In this guide, we list the directives and regulations for which the CE mark is required. Each directive and regulation also includes a product list andother requirements that EU importers and manufacturers must be aware of.

The European Commission requires that manufacturers place the CE mark on their products if such products are covered by one or more of the CE marking directives or regulations. Additional requirements also apply, as we explain in the next section.

Currently, there are more than 20 CE marking directives and regulations. Each one covers a certain product scope and describes the technical and regulatory requirements for manufacturers, importers, and distributors.

Many CE marking directives and regulations do not list the specific products under their scope. Instead, these list the general product scope (e.g. input and output voltage). Therefore, it is sometimes confusing for manufacturers or importers to determine which particular directive or regulation applies to their products.

CE marking directives and regulations specify technical, regulatory, environmental, or other requirements for manufacturers, importers, or distributors. Each directive and regulation have different requirements for the product it covers. Here we summarized some general requirements:

The Radio Equipment Directive (RED) establishes a regulatory framework, including electrical safety, electromagnetic compatibility, radio spectrum use efficiency, and other circulation requirements, for the radio equipment placed in the EU market.

Note that radio equipment is defined as any electrical or electronic device that intentionally emits and/or receives aiming at radio communication and/or determination.

Also, according to the directive, if the manufacturer or importer demonstrates compliance via relevant harmonized standards, then the conformity assessment procedure might be completed without Notified Body involvement.

However, if the manufacturer or importer has not applied harmonized standards – or such standards do not exist for the product – then a Notified Body shall be required, either via EU-type examination or conformity based on full quality assurance.

According to Article 2 of the Directive, ‘radio equipment’ is defined as any electrical or electronic product that intentionally emits and/or receives radio waves for the purpose of radio communication. This can include WiFi, LTE, 5G, Bluetooth or GPS-enabled devices.

a. EN 303 354 V1.1.1 Amplifiers and Active Antennas for TV Broadcast Reception in Domestic Premises; Harmonised Standard Covering the Essential Requirements

b. EN 300 422-1 V2.1.2 Wireless Microphones; Audio Pmse Up to 3 GHz; Part 1: Class a Receivers; Harmonised Standard Covering the Essential Requirements

The RoHS Directive restricts the use of hazardous substances in electrical and electronic equipment (EEE) and establishes waste disposal methods for such products in order to protect human health and avoid environmental pollution.

The RoHS Directive applies to almost all electronic products placed in the European Union market, although there are some exemptions listed on the annexes of the directive.

b. EN IEC 63000: Technical Documentation for the Assessment of Electrical and Electronic Products with Respect to the Restriction of Hazardous Substances

The Ecodesign Directive sets up the regulatory framework for improving the performance of the so-called “energy-related products”, that is electrical and electronic products that might have a big impact on energy consumption.

The directive mainly sets compulsory requirements on the energy efficiency of household appliances and other products, with the goal of protecting the environment.

The Toy Safety Directive establishes safety requirements for toys and certain types of children’s products intended to be used by children under 14 years of age.

It requires that products under the scope of the directive must follow the technical requirements regarding the chemicals and heavy metals concentration limit, mechanical/physical properties specification, flammability rate, and more.

Annex I of the directive lists exempted products such as puzzles with more than 500 pieces, and bicycles with a maximum saddle height higher than 435 mm.

The Personal Protective Equipment (PPE) Regulation establishes designing and manufacturing requirements for personal protective equipment (PPE) placed in the EU market for the purpose of protecting the health and safety of the user, either on worksites or other places that present potential physical danger.

The regulation classifies PPE into Category I, II, or III, depending on the level of risk of the environment associated with their use. The hazardous levels are arranged in ascending order.

Annex I of the Personal Protective Equipment Regulation established three risk classes for which PPE is intended to protect users. Below we explain the differences among these classes.

contact with cleaning materials of weak action or prolonged contact with water; contact with hot surfaces not exceeding 50 °C or other types of relatively minor risks take place in the working environment. Examples of Category I PPE include:

Protective equipment that is intended for military use, self-defense, and resistance to non-extreme climate conditions are often exempted from the PPE Regulation, although there are some exemptions, which you can find in the text of the regulation itself.

The Construction Products Regulation (CPR) established rules and standards for products used for construction purposes in the EU. The Regulation provides a regulatory framework to assess the performance of construction products from the perspective of mechanical resistance, stability, flammability, health, environmental impact, and more.

According to Annex III of the regulation, when the product is covered by harmonized standards then Notified Body involvement might not be necessary in order to complete a declaration of performance.

“‘construction product’ means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works;”

The Medical Devices Regulation applies to medical devices and their accessories and establishes a regulatory framework for the safety and health of the patients and users.

“This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.”

‘Medical Device’ can mean any instrument, apparatus, appliance, material, or other articles intended to be used for diagnosing, preventing, monitoring, predicting or alleviating disease, disability, physiological or pathological problems.

The regulation classifies medical devices into four classes: Class I, IIa, IIb, and III, where the medical devices of Class III hold the highest risk. The higher the number is, the stricter the rules that apply to the products.

Class IIa: Medical devices that have some potential low to medium risk and can generally be used for less than 30 days. Products belonging to this category include surgical gloves, hearing aids, and diagnostic ultrasound machines.

Class IIb: Medical devices that might constitute medium to high-risk to the patients and are generally designed to be used for more than 30 days. Products belonging to this category include long-term corrective contact lenses and surgical lasers.

Class III: Medical devices that have the potential highest risk. Products such as cardiovascular catheters, aneurysm clips, hip-joint implants, and prosthetic heart valves are considered as Class III medical devices.

a. EN IEC 60601: Medical Electrical Equipment – Part 2-83: Particular Requirements for the Basic Safety and Essential Performance of Home Light Therapy Equipment

b. EN ISO 17664: Processing of Health Care Products – Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices – Part 1: Critical and Semi-critical Medical Devices

The In-Vitro Diagnostic Medical Devices Regulation lays down rules and regulatory requirements for in-vitro diagnostic medical devices intended to be used by humans in the EU.

c. EN ISO 25424: Sterilization of Health Care Products – Low Temperature Steam and Formaldehyde Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

The Measuring Instruments Directive regulates measuring instruments placed in the market of the EU. In particular, according to the regulation, measuring instruments shall provide an accurate measurement.

This directive stipulates that, for all non-automatic weighing instruments, it is compulsory to conduct a product performance assessment and ensure the products meet all essential requirements of the EU legislation before being marketed among the member states of the EU. Notified Body involvement is generally required.

“This Directive, which comes under the SAVE programme concerning the promotion of energy efficiency in the Community, determines the efficiency requirements applicable to new hot-water boilers fired by liquid or gaseous fuels with a rated output of no less than 4 kW and no more than 400 kW, hereinafter called ‘boilers’.”

The Noise Emission in the Environment Directive regulates the noise emissions into the environment generated by machinery used in outdoor areas, including the conformity assessment procedure and technical documentation.

The directive provides two options for certification of the regulated outdoor machinery. When such equipment is subject to permissible sound power levels, the Notified Body involvement is required in the aspects of product design manufacturing procedures.

The Gas Appliances Regulation covers a wide range of household appliances function by means of burning gaseous fuels for the purpose of cooking, heating, refrigerating, lighting, and washing. The regulation establishes harmonized standards and procedures from the aspects of design, structure, and safety.

“ ‘appliances’ means appliances burning gaseous fuels used for cooking, refrigeration, air-conditioning, space heating, hot water production, lighting or washing, and also forced draught burners and heating bodies to be equipped with such burners.“

The Pressure Equipment Directive regulates pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar gauge in terms of safety requirements, product design, and manufacturing procedures.

The directive classifies pressure equipment into four categories, ranging from I to IV. The hazardous levels are arranged in ascending order. Conformity with the directive requires Notified Body involvement. Note, however, for a product classified under the category I is generally optional.

“ ‘pressure equipment’ means vessels, piping, safety accessories, and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs.”

The Simple Pressure Vessels Directive establishes procedures for simple pressure vessels in terms of design, manufacturing, safety, conformity assessment procedures, free movement, and other essential requirements for these products.

The Lifts Directive regulates lifts in terms of design, manufacture, components, installation, safety rules, and maintenance methods. The directive provides standards for manufacturers, importers and owners of lifts to refer to.

(c) goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier.”

The Cableway Installations Regulation sets up rules for cableways designed with the purpose of transporting people. This regulation involves requirements for the design, components, construction, subsystems, installations, infrastructure, operation, safety analysis, and the process of the cableway entry into service in the EU market.

a. EN 1709: Safety Requirements for Cableway Installations Designed to Carry Persons – Precommissioning Inspection, Maintenance, Operational Inspection and Checks

The Rail System Interoperability Directive sets standards for community rail systems concerning the design, construction, placement in service, upgrading, renewal, operation, and maintenance of the system, as well as the health condition of the staff who operate the system.

The ATEX Directive defines the essential health and safety requirements and conformity assessment procedures for equipment and protective systems used in an environment with potential explosive hazards in the EU market.

Most of the products regulated by this directive require Notified Body involvement. However, there are some exceptions, which can be found in Article 13 of the Directive

‘pyrotechnic article’ means any article containing explosive substances or an explosive mixture of substances designed to produce heat, light, sound, gas or smoke or a combination of such effects through self-sustained exothermic chemical reactions.”

The CE mark is a mandatory conformity mark on many products sold in the single market European Economic Area (EEA). The CE mark certifies that a product has met EU consumer safety, health, or environmental requirements.

By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 27 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.

The CE mark is a declaration by Hope Industrial that the product conforms with applicable requirements set out in EU law necessary before applying the mark. In order for an industrial monitor or related product to display the CE mark, Hope Industrial products have met some or all of the following Directives:EC-DirectiveSubjectDocument No.Low Voltage DirectiveProducts with a voltage rating of 50-1000 VAC or 75-1500 VDC2014/35/EU

Electromagnetic Compatibility (EMC) DirectiveApparatus liable to cause electromagnetic disturbance or which is liable to be affected by such disturbance2014/30/EU

More information on CE marking requirements is available directly from the European Commission, including "The Blue Guide," which provides detailed information.

RoHS Directive 2011/65/EU (Restriction of Hazardous Substances) is an included requirement for displaying a CE mark and restricts the use of some hazardous substances in electronics and electrical equipment sold in Europe. The Directive bans selling new products that contain more than specified levels of the following materials in the EU market: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants.

RoHS Directive 2015/863/EU amends the directive above and adds four additional substances, Bis(2-Ethylhexyl) phthalate (DEHP), Benzyl butyl phthalate (BBP), Dibutyl phthalate (DBP), Diisobutyl phthalate (DIBP).

RoHS-compliant parts must have less than or equal a maximum concentration of 0.1% (by weight) of lead, hexavalent chromium, mercury, PBB, PBDE, DEHP, BBP, DBP, DIBP and 0.01% for cadmium, unless the parts qualify for an exemption.

The first precondition that a manufacturer affixes the CE mark is that the medical device fulfills the "essential requirements" as laid out in Annex I of MDD, respectively the "general safety and performance requirements" as laid out in Annex I of MDR.

The second precondition is that the manufacturer performs a conformity assessment procedure. There a multiple procedures the manufacturers can pick depending on the risk class.

For class I devices the manufacturer does not have to involve any external party such as a notified body. In this case they affixes the CE mark with no number.

CE Certification is required for all recreational boats entering or being sold in the European Union. Manufacturers must test and document to ensure conformity to all applicable European directives and requirements. CE certification is obtained from Notified Bodies, organizations that are recognized by European states to conduct CE assessments and issue CE certification documents.

NMMA works closely with the International Marine Certification Institute (IMCI), a notified body in Europe that issues conformity certificates, to assist U.S. boat builders in the certification process. Certification by a notified body enables you to display the CE mark on your products and allows you free and open access to the European Union market.

It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through the US FDA.

Although the compliance requirements are similar in many ways, the European route is thought to be less bureaucratic, resulting in shorter times to market, greater acceptance rates of new devices, and lesser costs associated with obtaining conformity certification.

While the benefits of obtaining a CE marking are significant, regulations are always subject to change. New modifications to the European medical device requirements are making the process more similar to that of the FDA when it comes to establishing conformity.

By May 2020, a new Medical Device Regulation (MDR 2017/745) will go into effect throughout the European Union. Despite the changes, there still remains a clear path to establishing conformity and obtaining a CE marking that will allow your company to access European markets.

This article describes the path to compliance under European regulation and provides five key steps medical device companies must take in order to obtain a CE marking that allows product distribution into the EU marketplace.

You"ll need to determine which set of regulations applies to your device based on the nature of the device itself. You"ll either be subject to the Medical Device Regulation (MDR 1017/745) or the In Vitro Diagnostics Regulation (IVD 2017/746).

European regulations require that you consult Annex VIII of the Medical Device Regulation (MDR) to classify your medical device according to its risk profile. Classification criteria are based on the duration of contact with the patient, the degree of invasiveness of the device, and the parts of the body affected by use of the device, among other items.

A provided decision tree uses 22 descriptive rules to help you classify your device as either Class I, IIa, IIb, or Class III, according to the associated risks. Once this is completed, you"ll understand exactly which regulations apply to your device.

Establishing a compliant quality management system is essentially a global requirement when it comes to entering the medical device market. The QMS standards set forth by the European Commission are similar to those of the FDA and other organizations, and many medical device companies use ISO 13485 as a guideline for building an effective quality management system.

Quality management systems are sets of policies and procedures that involve and affect everyone at your medical device company. This includes everyone from the document controller charged with oversight of your QMS to the workers that follow those policies and procedures daily to ensure that your design and manufacturing processes are safe and effective.

An eQMS designed for the medical device industry is the best means of ensuring that your efforts to guarantee product quality and effectiveness get the best results. You"ll benefit from cloud-based document storage, document version control, enhanced data security, and superior organization that reduces your time to market.

Now that you"ve properly classified your device and implemented a quality management system at your organization, the next step is to ensure that your device meets the conformity requirements set out in European Commission regulations.

For most medical devices, you"ll have to review the requirements of the Medical Device Regulation (MDR 2017/745), ensuring that your device is deemed acceptable across several dimensions, including its appropriateness for the intended use, safety, labeling and packaging, effects of transportation and storage, and risk versus benefit for the end user. Annex I of this document sets out the general safety and performance requirements for affixing the CE marking.

If your medical device is in risk classes I, IIa, or IIb, you"ll be required to produce a technical file on your medical device that provides details on the conformity of the device and shows that you satisfy the Essential Requirements.

The requisite information for creating such a document should already be contained in your QMS and should be easy to source and assemble, provided your organization has implemented a software-based, searchable QMS.

For Class III devices, a Design Dossier should be compiled which contains the data of the technical file along with a description of the design process for the device.

Now that you"ve identified and classified your device, implemented a QMS, and prepared the documentation to illustrate your conformity with EU regulations, you"ll need to have your QMS and documentation audited by a notified body. One thing to note is some Class I devices can be self-certified and do not require an audit by a notified body.

A notified body is a third-party company that has been accredited by European competent authorities to conduct audits of medical device companies, and their products and systems. There are several large, international auditing and standards organizations that provide this service.

Once you"ve successfully passed your audit, you should be issued a CE marking certificate for your product along with an ISO 13485 certificate that establishes that your QMS is compliant with European standards.

The final step is to create a Declaration of Conformity. This is a legally binding document which declares that your device meets all of the essential requirements as laid out by EU MDR and any other applicable regulatory standards.

Overall, the actual process for obtaining a CE marking defined in MDR 1017/745 is similar to the previous process from MDD. However, there are some higher level changes to be aware of, such as:

Inclusion of New Devices - The MDR covers some categories of medical devices that are not currently intended for medical use, but that carries some of the same risks as medical devices that are covered under the new regulations. This change has seen items like contact lenses, dental filling material, and even breast implants subject to medical device safety requirements.

Focus on Post-Market Surveillance - The new MDR places more stringent requirements on medical device companies in regard to post-market surveillance, with the expectation that companies will gather information about the safety and effectiveness of their device in practice by conducting regular clinical evaluations.

New Traceability Requirements - Manufacturers are required to affix device and product numbers to the items they sell, in order to facilitate enhanced traceability and unique identification of devices.

Looking for a design control solution to help you bring safer medical devices to market faster with less risk?Click here to take a quick tour of Greenlight Guru"s Medical Device QMS software →

The Republic of Norway is currently not a member of the European Union, but strongly linked to the EU through various agreements (including the EEA and EFTA). This also applies to the approval process for products with wireless technologies. Here, Norway has joined the EU guidelines and also uses the Radio Equipment Directive and the associated CE marking as a guideline for market approval in Norway.

Accordingly, manufacturers must have their wireless products tested and certified in accordance with the requirements of the Radio Equipment Directive (RED). The resulting CE marking not only allows market approval for Norway, but also for the countries of the European Union, as well as for a large number of other countries that use the Radio Equipment Directive and the CE marking as the basis for market approval.

The CE Marking is permanently valid, so that unchanged products do not have to be re-certified. For approval, manufacturers must schedule between six to eight weeks. After certification, a manufacturer is required to visibly display the CE mark on the product, packaging and, if applicable, in the enclosed instructions.

As CETECOM, we offer our customers all services required for European market approval. As an ISO 17025 accredited laboratory, we carry out measurements in accordance with the requirements of the Radio Equipment Directive in our laboratories. Our Notified Bodies then take the approval process. Throughout the entire testing and certification process, which ensures the rapid access to the European market and at the same time, provides you with advice on the other international approvals based on a CE certification.

On our website you will find more information about our full product testing and certification services. You can also find further information on the RED specifications and the associated certification label, as well as many other approval regimes in our certification database CETECOM CERT.