CE Mark Certification

CE (Conformity European)

For many products to be sold in the EU, CE labelling is necessary. When a product bears the CE label, it means that the maker has evaluated it and determined that it complies with EU standards for environmental, health, and safety protection. It is necessary for any goods created anywhere in the world that are later sold in the EU.

Why is CE mandatory?

Only products for which EU specifications exist and mandate the application of CE marking are subject to the requirement.

Certain products must simultaneously comply with multiple EU regulations. When applying the CE marking to your product, check sure it conforms to all applicable standards. It is prohibited to apply the CE marking to products for which there are no EU specifications or for which such application is not necessary.

The CE mark signifies that the goods, regardless of its place of origin, may be freely traded in any region of the European Economic Area. It includes the CE logo and, if applicable, the notified body’s four-digit identification number used in the conformity assessment process. The initials “CE” stand for European conformity.

Characteristics of CE marking

- The CE marking must be visible, legible, and permanently applied on the product by the manufacturer or its authorized representative in the European Union in accordance with its legal format.
- When a manufacturer applies the CE marking to a product, it signifies that it complies with all applicable directives and regulations’ Essential Health and Safety Requirements.
- For instance, the Machinery directive primarily applies to machines, but it also frequently:
- Low-voltage guidance
- Besides from the EMC directive, there may also be other rules or directives, such as the ATEX directive or other legal requirements, such as those for materials used in food contact.

When a machine’s manufacturer applies the CE marking, they commit to and guarantee that they have conducted all necessary tests, evaluations, and assessments to ensure that the product complies with all applicable standards.

The CE marking must be at least 5 mm in size, and if it is larger, its proportions must be maintained.

We Deals in Below Regulations

Personal Protective Equipment (PPE) Regulation – (2016/425/EU)

Personal Protective Equipment (PPE) is designed to reduce the exposure of workers to hazards that can lead to serious injuries or illnesses. PPE needed for the prevention of falls includes safety harness, lanyards, energy absorbers, horizontal and vertical lifeline systems, fall arresters, etc.

When it’s not possible to entirely remove a fall hazard or prevent a fall from happening, then personal fall arrest systems that allow a person to cascade but keep them from striking the ground or a lower object should be put in place. Fall protection gear also helps make working at heights safer. In precise terms, this phrase refers to all steps taken and tools used to avoid any plunge from heights. We certify all these products as per applicable EN standards & PPE regulations.

Low Voltage Directive (LVD) – (2014/35/EU)

As of April 20, 2016, the low voltage directive (LVD) (2014/35/EU) ensures that electrical equipment that falls within specific voltage ranges provides high levels of protection to European citizens and fully utilizes the single market.

A low voltage directive (LVD) addresses health and safety concerns regarding electrical devices that uses input voltages or output voltages between

In terms of alternating current, 50 and 1000 volts
75 and 1500 volts for direct current

It relates to a variety of electrical devices for both home and business use, including

Cables for home appliances
Energy supply systems
Certain parts of laser equipment, such as fuses
Electrical Enclosure
Control Panels, etcetera.

Electro Magnetic Compatibility (EMC) – 2014/30/EU

When linked or placed near each other, electrical gadgets and installations can interact with one another and cause interference. This includes TV sets, GSM phones, radios, washing machines, and power lines. EMC (electromagnetic compatibility) is an area of electrical engineering that works towards the correct functioning of multiple pieces of equipment in a shared electromagnetic environment – all while keeping these disturbances within an acceptable control range. This is regulated by the EMC Directive 2014/30/EU.

Machinery Directive – 2006/42/EC

A European Union regulation addressing machinery and certain machinery components, the Machinery Directive combines voluntary harmonized standards with safety and health requirements. As part of the Machinery Directive, interchangeable parts, lifting attachments, chains, ropes, and webbing, detachable mechanical transmission components, and machinery that has not been completely assembled are covered.

Directive 2006/42/EC focuses on safety. It outlines the specifications items must meet, both for the safety of associated items and for the safety of machines. The machinery must be used in a way that reduces, or better yet eliminates, any potential for dangerous circumstances. The method for determining compliance is also outlined.

Construction Product Regulation(CPR) – 305/2011/EU

Construction Product Regulation (CPR) establishes harmonized guidelines for marketing building materials in the EU. Building materials are evaluated using a standard technical vocabulary under the regulation. In order to compare the performance of products from various procedures across various nations, it ensures that trustworthy information is available to experts, government officials, and customers.

A performance-based methodology is used by the CPR in setting guidelines for the marketing of construction products. In order to meet national standards, manufacturers disclose performance data about their products in a distinctive, standardized way. Most of the procedures and guidelines for evaluating the performance of items have been developed by the European standardization system. In accordance with the regulatory requirements set forth by Member States and, where required, by the European Union, the procedure follows mandates or standardization requests issued by the European Commission.

Medical Device Regulation (MDR) – EU 2017/745

A European Union rule on clinical testing and marketing of medical devices intended for human use is known as rule (EU) 2017/745. On May 26, 2021, it will remove Directive 90/385/EEC, which addresses active implanted medical devices, and Directive 93/42/EEC (MDD), which addresses medical devices. A number of significant advancements are made in the conformity assessment process for medical devices with the following goals:

Improve the quality, dependability, and safety of medical equipment sold in Europe.
Increase consumer and professional access to medical device information by increasing openness.
Be more vigilant and pay close attention to used equipment markets.

The changes to the regulations will affect businesses in various ways depending on the devices they create and their role (e.g. manufacturer, importer, authorized agent). It is likely that substantial alterations to the compliance process, quality management system, and technical documentation will be required before they are able to meet the requirements; these adjustments must then be implemented, confirmed as appropriate for each device class and role, and finally certified.

Radio Equipment Directive (RED) – 2014/53/EU

It establishes a regulatory framework for putting radio equipment on the market under the radio equipment directive 2014/53/EU (RED). By setting essential requirements for safety and health, electromagnetic compatibility, and efficient use of the radio spectrum, it ensures a single market for radio equipment. The legislation also provides a basis for further regulations governing some additional aspects, such as privacy protection, personal data protection, and fraud prevention. Aside from interoperability, emergency access, and compliance with radio equipment and software combinations, there are also other factors to consider.

Pressure Equipment Directive (PED) – 2014/68/EU

Stationary pressure equipment with a maximum pressure greater than 0.5bar is covered by the Pressure Equipment Directive (2014/65/EU) for design, manufacture, and conformity testing. In the Pressure Equipment Directive, which becomes effective on July 26, 2016, a high level of safety is ensured while ensuring free movement of products within its scope. As a result of administrative and engineering controls being ineffective or not practical in reducing these risks to acceptable levels, personal protective equipment is used to lessen employee exposure to dangers. There are dangers that require personal protective equipment. However, PPE does not eliminate the risk at its source, and personnel may be exposed to the risk if it breaks down.

Atmospheres Explosives(ATEX) – 2014/34/EU

The ATEX abbreviation stands for “Atmospheres Explosive”. It is the basis of European Directive 2014/34/EU concerning explosion-proof electrical and mechanical equipment, components, and protective systems. This Directive has been in effect since July 1st, 2003 and applies to all new protective systems and equipment. Goods utilized in potentially explosive environments must comply with the regulations of this Directive; responsibility for meeting this requirement falls on the manufacturer. All electrical, mechanical, and protective systems installed in hazardous atmospheres are subject to the provisions of ATEX Directive 2014/34/EC.

In Vitro Diagnostic Regulation (IVDR) – EU/2017/746

Significant changes are being made to the regulatory framework for releasing IVD’s onto the European market. After a five year transitional period, the IVDR went into the effect on May 26, 2022, at which point all new IVDs and Class A non-sterile devices had to conform to the regulation. All devices must comply with IVDR by May 26, 2027, and IVDD-certified devices cannot be used after that date. As algorithms and software are used more frequently, the regulation’s goals are to prevent country-by-country interpretations, clarify the manufacturer’s responsibilities, and safeguard public health. More resources are frequently needed to deploy and sustain post-market device launch with IVDR than IVDD since it is more extensive. The rule introduces the risk classifications A, B, C, and D for IVD categorization. In Annex VIII, there are seven categorization rules listed. The categorization guidelines are clarified in MDCG advice 2020-16, which also offers classification examples. Only gadgets in the class A (lowest risk) category are exempt from the need for notified body oversight

Restriction of Hazardous Substances (ROHS) – 2015/863

The EU RoHS 3 Directive, often known as the “RoHS 3 Directive,” forbids the use of hazardous materials in electrical and electronic equipment (also known as “EEE products”). RoHS stands for Restriction of Hazardous Substances in Electrical and Electronic Equipment. Any business that imports products into the European Union that contain electrical components is impacted by RoHS. On July 22, 2019, RoHS 3, or Directive 2015/863, became law. The new guideline increased the number of forbidden compounds from six to 10 by adding four new forms of phthalates.

We work closely with you and carry out research to understand your needs and wishes.