ce certification lcd panel quotation

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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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.”

CE, abbreviated from French "Communate Europpene", is the meaning of the European Community, referred to as the European Union. The CE mark is mandatory in the EU market. Regardless of whether the products are produced by companies within the European Union or produced by other countries, if they want to circulate freely on the EU market, they must be affixed with the CE mark to indicate that the products comply with the EU"s The New Approach to Technical Coordination and Standardization. technical harmonization and standardization).

Those without the CE mark cannot be sold on the market. Products that have been affixed with the CE mark and entered the market and found that they do not meet safety requirements shall be ordered to withdraw from the market. Those who continue to violate the relevant CE mark provisions of the directive will be restricted or prohibited from entering the EU market or Forced to exit the market.

CE certification is available in 32 special economic zones in Europe, including: EU 28, EFTA Europe 3/4, Turkey. Products with CE marking can be freely distributed in the European Economic Area (EEA).

Specific EU 28 countries list: Belgium, Bulgaria, Czech Republic, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Croatia, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Austria, Poland , Portugal, Romania, Slovenia, Slovakia, Finland, Sweden, United Kingdom.

Note 1: EFTA includes four member states of Switzerland (Iceland, Norway, Switzerland and Liechtenstein), but CE marking is not mandatory in Switzerland;

Note 2: Because of the colonial era, CE certification is widely used and widely recognized worldwide. Some countries in Africa, Southeast Asia, and Central Asia may also receive CE certification.

In order to understand the product range of CE, you must understand the NLF regulations of CE certification. NLF stipulates that products within its scope need to be CE certified. The EU"s new legislative framework NLF currently has 22 directives, which are the following:

Note: NLF refers to the EU ’s new legislative framework. The full name “New Legislative Framework” is a European Union ’s regulation to strengthen the market regulatory framework and recognition system for products. In addition to the unified definition of the concept, specific provisions have been made on national accreditation bodies and accreditation systems, the European market regulatory framework, product market access control, general rules for the use of logos, and European Community funding.

After familiarizing yourself with the regulatory framework, you can classify the corresponding products. The CE certification scope is very broad. Generally speaking, most products exported to the EU require CE certification. CE certification is mandatory for electronic products and toys exported to Europe, such as:

Communication products: telephones, wired and wireless main and auxiliary machines, fax machines, answering machines, modems, data interface cards and other communications products.

Wireless products: Bluetooth BT products, wireless keyboards, wireless mice, wireless readers, wireless transceivers, wireless microphones, remote controls, wireless network devices, wireless image transmission systems and other low-power wireless products;

6. After the product test meets the requirements, provide a product test report or technical construction file to the applicant company, and issue a CE certificate after the test is passed.

3. Safety design documents (including key structural drawings, that is, design drawings that can reflect the climbing distance, clearance, number of insulation layers and thickness);

9. Registration certificate of the product within the EU (for some products such as Class I medical devices, general IVD in vitro diagnostic medical devices);

CE certification is a kind of enterprise commitment to consumers, which increases the level of consumer trust in products; products with the CE mark will reduce the risk of sales in the European market.

The EU"s laws, regulations and harmonized standards are not only large in number, but also very complex in content, so it is a wise move to save time and effort and reduce risks by obtaining the assistance of a designated EU agency;

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The CE Mark, when affixed to a product, shows that the product complies with all safety requirements stipulated by EU Directives. Products with this symbol can be freely distributed within the EU market.

Manual on borderline and classification in the community regulatory framework for medical devices: Borderline Manual v1.22 especially sections 8.4 and 9

The answer to this question is all based on its intended use. It shall be for diagnostic, treatment, prognosis, prevention purposes. It is stated in the definition of medical device in article 2 of the MDR.

The MDCG 2019-11 ref.2 has two decision trees that are an help to qualify software as medical device or in-vitro diagnostic device. The guidance contains also a comprehensive list of examples in annex 1 and 2, with types of software which qualify or don"t qualify as medical devices.

These software are not medical devices, thanks to the decision tree found in MDCG 2019-11. The most common situation is to answer "Yes" to the Decision step 3 of that guide.

Warning: these types of software are not qualified as medical devices in EU. But they may qualify as medical devices in other regions of the world, especially in the US.

However, even with the help of the guidances, it may be difficult to qualify software as medical device. Borderline cases exist, usually with standalone software, like software that could be used at the same time for general wellness purposes or for treatment purposes. In this case, the qualification of medical device stems from the claims in the intended use.

The intended use of a mobile app claims that it records and computes statistics about what the user eats and the quantities of carbs, fat, etc. It is for general wellness purposes, it is not a medical device.

The intended use of the same mobile app (technically) now claims that it records and computes statistics about what the user eats and the quantities of carbs, fat, for diabetes management. It is for management of diabetes - an aid to the treatment of a disease - it is a medical device.

The Borderline Manual ref.3 is also a good source of information to determine whether software is a medical device or not. Warning: this document is applicable to the MDD. Use it for qualification, hence the definition of a medical device didn"t change to much. Don"t use it for classification, hence the classification rules have changed with the MDR.

The intended use is the responsibility of the manufacturer. Having an intended use in the scope of medical devices or not can also be seen as a management decision. Thus, same software could be qualified as medical device or not, depending on management decision on what will be claimed with that software!

Imagine that a manufacturer sells software with an intended use for general wellness. But then promotes its software for diagnostic or treatment purposes or for use combined with a medical device in such a way that it can be qualified as an accessory of the device. Then it is by real use a medical device, even if it"s not claimed in the intended use.

Qualifying software as a medical device can be a difficult task hence the result has heavy consequences in terms of time and money, and in responsibility.

The guidances quoted above may not have enough information for peculiar cases. Thus it"s worth contacting a notified body or a competent authority to assess the status of your software.

If you have a software platform delivering various services, qualifying one subset of these services as medical device doesn"t qualify the whole platform as a software medical device. Fortunately, section 7 of the MDCG 2019-11 allows software editors to apply a modular approach.

Only the modules containing the functions with a medical purpose will be qualified as medical devices. The rest of the software platform will remain health software outside the scope of the MDR. The condition to have such status is to ensure a architectural segregation between medical devices and non-medical device components.

Each medical device shall be classified in one class: class I, class IIa, class IIb or class III. It depends on the level of risk generated by the use of the device. This is done by reviewing the rules in the annex VIII of the MDR ref.1:

Software, which drives a device or influences the use of a device, shall fall within the same class as the device., this is the rule for software connected to another device, hardware or software.

Software, which only displays data collected from the device, may not be at first sight seen as “driving” the device. But if the user uses data provided by the software to modify the state of the device, then the software “influences” the device.

Just for information, the rule 1, applicable to devices not in contact with a patient, is always applicable to standalone software. That"s not a very useful rule, as is states that such device is in class I. This rule is always overtaken by other rules discussed below.

Standalone software is considered as an active medical device (powered by electricity. No current, no software). Active medical devices are governed by rules 9 to 13. The purpose of the MDCG 2019-11 guidance ref. 2 is to give some explanations on how to interpret these rules.

Devices classified by this rule are mostly electrical equipment used in surgery such as lasers and surgical generators. In addition there are devices for specialized treatment such as radiation treatment. Another category consists of stimulation devices, although not all of them can be considered as delivering dangerous levels of energy considering the tissue involved.

Vital physiological processes and parameters include, for example respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature.

It edited a manual (ref. 3) on borderline classification of medical devices, for which there was a difficulty to apply rules of the EC directive. A chapter deals with Picture Archiving and Communication System (PACS). PACS shall be class IIb, IIa or class I, depending on their purpose. Here are some examples. If the PACS:

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

The MDR definition of medical device contains the words diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. The rule 11 places software in class IIa when it is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes

Diagnosis, monitoring, prediction, prognosis, treatment, alleviation are diagnosis or therapeutic purposes. There remains only prevention outside the scope of rule 11. Thus, there is 99% chance that your software is in class IIa. The MDCG 2019-11 doesn"t say the contrary.

It reduces the probability to place your software in a class higher that class IIa, by combining the impact of the information provided by software with the patient state.

The definitions of significance of information and state of health come from another guidance published outside EU: IMDRF/SaMD WG/N12 FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.

To treat/prevent or mitigate by connecting to other medical devices, medicinal products, general purpose actuators or other means of providing therapy to a human body

To diagnose/screen/detect a disease or condition (i.e., using sensors, data, or other information from other hardware or software devices, pertaining to a disease or condition).

Situations or conditions where accurate diagnosis or treatment is of vital importance to avoid unnecessary interventions (e.g., biopsy) or timely interventions are important to mitigate long term irreversible consequences on an individual patient’s health condition or public health. SaMD is considered to be used in a serious situation or condition when:

Situations or conditions where an accurate diagnosis and treatment is important but not critical for interventions to mitigate long term irreversible consequences on an individual patient"s health condition or public health. SaMD is considered to be used in a non-serious situation or condition when:

The MDR defines several procedures to CE mark a device. They are described in article 51 of the MDR, combined with article 61 for clinical evaluation, and articles 83 to 87 for post-market surveillance.

The principle of these procedures is to build a quality management system and build technical file containing data about the medical devices. The conformity assessment procedure to apply differs with the class of the medical device. Here are the possible combinations for standalone software:

The Annex XI – Part B Product Verification is not suitable for software, as the product verification requires to examine every device individually. Annex XI – Part B targets hardware devices, not standalone software.

Standalone software by essence doesn"t enter into contact with a patient, isn"t implantable, doesn"t contains substances, and isn"t combined with drugs. Thus, conformity assessment procedures don"t require a second review of technical documentation by subject matter experts after the review by the notified body.

Software is also characterized by the absence of categories or generic groups (e.g. implants with several sizes). When a software editor has several software, they are marketed individually or as a software suite, each software in the suite being a single product (think about MS Office).

The Harmonized Standards (see ref. 4) for software are IEC 62304, IEC 62366 and section 14 of IEC 60601-1. We can also add IEC 82304-1, not harmonized yet but recognized by the FDA and under the radar of Notified Bodies. All four standards require manufacturers to have a design control procedure for software.

Software is very prone to be updated every year, with major changes to existing functions or new functions. Every year is quite a good frequency. Trying to update software at a higher pace is a difficult task, not controlled by the editor. The Notified Bodies impose their rhythm.

If software is updated on a yearly basis with major changes (something common for standalone software), it will require a annual post-market surveillance report (PSUR), no matter the class,

There are differences of sampling plans for class IIa and class IIb after the initial conformity assessment. If you update your software every year, this sampling plan isn"t relevant, since the Notified Body will have to review the changes, no matter the class.

Annex IX is applied to the whole company, for every product in the scope of the Quality Management System. The company is ISO 13485 certified and most of them have an activity in medical devices only,

Annex X, and XI can be applied to a subset of products delivered by the company. It may be ISO 9001 certified for all its products. A subset of products is composed of medical devices, for which the company chose to apply the relevant annexes of the MDR,

Of course, every case may be found in the nature, like a company manufacturing only medical devices and applying other annexes than annex IX. But this is more and more frequent with the MDR to have software editors with a single product, which are ISO 13485 certified, and apply annex IX.

These steps shall be monitored very carefully. Some may be done by the customer and shall be double-checked. A divergence from expected behavior is very common with software. It’s mandatory to have procedures to handle these tasks to have software work properly.

Bug fixes and enhancements: A full quality system according to annex IX shall have procedures to manage bugs and enhancements. So do procedures according to annex XI. Collecting bug and enhancements is a mandatory task, based on the requirements of MDR article 10.

The IEC 62304 standard gives a comprehensive list of processes to implement in order to have software developed and maintained according the state of the art. Applying this standard is the best thing to do prior to any software medical device CE conformity project.

Step 1 for Class I (sterile or with a measuring function), Class IIa, Class IIb and Class III devices: the notify body delivers a certificate of conformity,

Of course, the notified body doesn’t establish the certificate of CE conformity in a snap of a finger. It reviews the whole documentation produced about the device. The process can take up to a year (yes, A YEAR). But if the documentation follows clearly a software design process compliant with the standards quoted above, then the job of the notified body is made easier. It should prevent them from asking troubleshooting questions about software and/or issuing non-conformities.

Laurel Electronics, Inc.hereby certifies that all products that it has manufactured and/or resold since 2000 meet all directives to achieve CE marking. The CE marking (an acronym for the French "Conformité Européenne") certifies that these products meet EU health, safety, and environmental requirements to ensure user safety. Test results have verified compliance with the following:

We compile the technical documentation for your product, including the CE requirements list. For this purpose, we check the documents you provide for completeness and validity.

By placing the CE marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the EEA. This also applies to products made in third countries which are sold in the EEA and Turkey.

Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.

CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.

If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.

Even if your product is manufactured outside the EEA, you must ensure the product bears CE marking if your product comes under the scope of a directive requiring CE Marking. Not all products sold in the EU need to bear CE marking.

CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:

If you have an enquiry about the Construction Products Regulations or if you would like information on the new requirements for structural steel, which came into force on 1 July you can email construction.products@communities.gov.uk.

Before you place a CE marking on a product, you need to establish which EU New Approach Directives apply to your product. You must not attach a CE marking to a product outside the scope of the directives.

There are more than 20 directives setting out the product categories requiring CE marking. The essential requirements that products have to fulfil, for example safety, are created at EU level and are set out in general terms in these directives. Harmonised European standards are issued with reference to the applied directives and express the essential safety requirements in detailed technical terms.

Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is required. These bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed on the NANDO (New Approach Notified and Designated Organisations) database.

If you manufacture a product it is your responsibility to test the product and check its conformity to the EU legislation (conformity assessment procedure). One part of the procedure is, as a general rule, a risk assessment. By applying the relevant harmonised European standards, you will be able to fulfil the essential legislative requirements of the directives.

The CE marking must be placed on the product by the manufacturer, or by his authorised representative within the EEA or Turkey. It must be placed according to its legal format to the product or its data plate. It must be visible, legible and impossible to remove. If a Notified Body was involved in the production control phase, its identification number must also be displayed. It is the manufacturer’s responsibility to draw up and sign an ‘EC DoC’ proving that the product meets the requirements. That’s it, your CE-marked product is ready for the market.

Once you have satisfied the conformity assessment requirements for CE marking you must attach the CE marking to your product or its packaging. There are specific rules for using the CE marking for your product, as well as rules for the reproduction of the CE marking logo.

In general you should attach the CE marking to the product itself but it may also be placed on the packaging, in manuals and on other supporting literature. Rules covering the use of the CE markings vary depending on the specific EU directive that applies to the product and it is advisable to study the applicable guidance. The following general rules all apply:

Member states will ensure they implement the regime governing the CE marking. They will take appropriate action in the event of improper use of the marking and provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties will be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use

The general principles of the CE marking are contained within Regulation (EC) No 765/2008 which sets the requirements for accreditation and market surveillance relating to the marketing of products. You can read the CE marking regulations on the Europa website.

the CE marking is placed onto the product or to its data plate - if this is not possible or not warranted because of the nature of the product, it must be placed onto the packaging and accompanying documents

You must keep certain documentation once you have placed the CE marking onto your product. This information can be requested at any time by the Market Surveillance Authorities to check that a CE marking has been legitimately placed on a product.

There are many bodies that enforce CE marking legislation to prevent misuse of the CE marking and to ensure that product safety is maintained to a high standard.

Enforcement, or market surveillance, is undertaken by nominated public authorities (Market Surveillance Authorities) in each member state, and each state has separate ways of enforcing the legislation once it has been implemented into national law.

Market Surveillance Authorities and processes will vary depending on which directives are applicable to your product. The following bodies, amongst others, are responsible for CE marking enforcement in the UK:

If an enforcement body finds your product does not meet CE marking requirements, they will often provide you with an opportunity to ensure it is correctly CE marked. If you fail to comply with this, you will be obliged to take your product off the market. You may also be liable for a fine and imprisonment.

The CE marking indicates that a product has met safety, health and environmental protection requirements set forth by the EU and is required for products sold within the European Economic Area (EEA).

Since the UK is no longer a part of the EEA, the CE marking does not apply to products sold within Great Britain (England, Scotland, and Wales). There are special circumstances for the CE mark within Northern Ireland.

The UK still sees value in having products meet safety, health, and environmental regulations and therefore put in place its own required marking called UKCA (United Kingdom Conformity Assessed).

The new marking affects any business that sells products within the England, Wales, and Scotland markets. There are special circumstances for Northern Ireland businesses.

There are special rules in place for the following goods: medical devices, construction products, marine equipment, rail products, and transportable pressure equipment.

The difference between the two markings is the geographical markets that it covers. CE is only recognized within the EU and Northern Ireland markets, while the UKCA mark is for the GB market (England, Scotland, and Wales). The rules and regulations behind the marks are the same, but the marks are not interchangeable.

UKCA affects your business if you sell goods or plan to sell goods within the UK market, with the exception of Northern Ireland businesses. If you do not comply with UKCA by the enforcement date, then your goods cannot be sold within England, Scotland or Wales.

If you previously sold products with the CE marking within the Great Britain market and you want to continue selling in this geographical region, you will need to update those products to also conform to UKCA.

Though Brexit took effect at the beginning of 2021, the UK has issued grace periods for certain items such as the UKCA mark. It also has extended the enforcement date for the mark due to the disruption by the pandemic.

Under the grace period by the UK, existing products may continue to be sold until December 31, 2022 with only the CE mark while Great Britain and EU rules are aligned. If either changes their rules before that date, then the CE mark will no longer be recognized within England, Scotland, or Wales.

It is highly recommended to start conforming your products as soon as possible to UKCA if they will be sold in the GB market. For your existing products that have the CE mark and are sold within Great Britain, it is very risky to rely on the CE mark to cover your product within these countries before the enforcement date.

It is your responsibility to ensure your products meet the regulations of the countries that you are selling in. A good contract manufacturer will help shoulder this responsibility by proactively reviewing your planned markets and help in coordinating the certification of your product for these markets. Find out more on how to qualify a good manufacturing partner.

Certifying your products correctly allows you to pass government requirements and gives assurance to your consumers that the product is safe and reliable by their country’s standards. If your market includes Great Britain, start the transition to UKCA today to be in compliance by January 2023.

It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question.

Actually, it is similar to going to a builder, say that you want a six-room house on two acres, and asking to know the costs. That question is simply impossible to answer. There are far too many variables. It is the same with CE marking and CE certification. There are so many variables that can affect the price you pay. You don’t buy CE marking by the pound.

The price of CE certification can differ greatly from one product to another. I have seen prices range from $ 64 to $ 64,000. The price is often affected by which certification procedure applies to the product, whether the company can do some or all of the conformity assessments themselves, as well as the level of support needed to prepare the required compliance documents, Technical File, user manuals, and product labeling.

Which CE certification procedure or procedures applies/apply, is based on the technical specifications of a product, as well as its ‘intended purpose’. Only when these factors are clear, the correct CE marking directive or directives (yes, a product can be covered by more than one CE directive at the same time), European harmonized standards, and certification procedure can be determined.

In many cases, the CE directives offer two or more certification procedures that may be used. The costs associated with one or the other procedure can vary, and thus this is one of the aspects to keep in mind.

With this information, you can compare quotes from service providers such as test laboratories, certification bodies, and consultants and ensure that will provide the same service. (Compare apples to apples!)

This myth has cost a lot of companies a lot of money. In almost 90% of the cases, the CE marking regulations allow products to be self-certified for CE marking. In other words, you can do the CE marking yourself and you are not required to have the product certified by a third-party certification body. Obviously, CE marking self-certification can save your company a lot of time and money.

There are testing and certification bodies that are accredited for various international markings and certification schemes. With one basic test in combination with some targeted additional tests, your product can be approved for many markets, and thus you can spread the costs of certification over a bigger number of products.

I can give you a practical example: one of my clients manufactures a small optical inspection tool (a small car with a video camera) with an RF remote control module. The RF module was purchased from a vendor, and it already was CE approved. And as a result, my client did not have to test his product against the RF standards.

What I mean here are the costs of the persons who will have to dedicate time to the initial CE (self) certification, and afterward to keep updated with the regulations and standards.

As you can see there are many things to consider. All aspects mentioned above have an effect on the costs. In most cases, you can do a lot yourself, possibly with some guidance and instructions, thus saving a lot of money. Risk analysis, the compilation of the Technical File, conformity assessment against essential requirements of the directives and standards, and the Declaration of Conformity. These all can be done by you or your colleagues if you invest a little time in learning how to do it.

The biggest costs in CE certification are inherent to the time that test laboratories, certification bodies, and consultants need to spend on your products. I think that by looking at your product, you can already estimate that the time investment for conformity assessment, risk analysis, or the compilation alone is at least a full day of work, and likely more. Multiply this with a reasonable hourly fee, and you will conclude that the cost of CE certification easily exceeds $1500. For product testing alone you often need several days to run the required test procedure. I have seen wear and tear tests for construction products that take 1 month!

Surely, you may find laboratories and consultants in the market who claim they can do it for a very low fee. My experience and the experience of my clients with these companies is that the provided services are very cheap as well. Please consider this: the CE marking is about providing evidence that the product complies with the applicable requirements. In the case you have to involve a test laboratory or certification body, it is better to use a well-established, reputable company than a cheap unknown company. Because when your product’s CE compliance is challenged, its acceptance by authorities and your customers depend on the reliability of the (test)certificate and report.

At CEMARKING.NET, we have developed a Six Step CE Marking Framework that helps you to do as much as possible yourself, thus reducing the costs of CE marking. We offer this Framework as an On-Line Workshop, as a Coaching Program, and as a Done-For-You service. The first step is dedicated to determining which directives and standards apply to your products, and how you can do the CE marking efficiently and in a cost-effective way. For this, we conduct a documentation review and a gap analysis. We offer this first step of our framework as a separate service. That means you can get a report with an overview of the applicable requirements and recommendations with the steps you need to take, without investing in the full-service package. Contact us for more information on our services.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Blood Banking:CMP requirements will be revised to increase from 2 to 8 points in blood banking for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

CMP requirements will be revised to increase from 2 to 8 points in chemistry for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

CMP requirements will be revised to increase from 2 to 8 points in cytology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Gynecologic Cytology:CMP requirements will be revised to increase from 2 to 8 points in gynecological cytology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

CMP requirements will be revised to increase from 2 to 8 points in histology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Hematology:CMP requirements will be revised to increase from 2 to 8 points in hematology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Microbiology:CMP requirements will be revised to increase from 2 to 8 points in microbiology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are n