CE Marking is a certification mark that ensures conformity to the rules and regulation of the health, safety & environmental aspects for products sold in the European Economic Area (EEA).

The CE Marking is also found on products that are exported to various other regions besides Europe. It is seen as a credible source of a high standard throughout the world. As such, the application of CE standards on products enables you to reach new markets more easily.

CE Marking is considered as an authoritative stamp on the manufacturer’s conformity in following EU regulations on products with respect to health, safety and environment. CE Marking shall indicate that the product is free to enter the EEA. CE Mark is essential for all products that are exported or imported from EEA. The manufacturer shall affix the CE Marking to the products but must take certain obligatory steps before using it. CE Marking is also considered as a trade passport since it allows free market of products in EEA.

By affixing the CE Mark, the manufacturer takes the complete responsibility of the product and following the rules and standards as applicable by the European Union. The CE Mark has helped the European Markets to improve its product quality and various other factors that have provided greater lifestyle to its people. There is no restriction for producing a product having the CE Mark outside of the EU region. Generally, the CE Marking is supposed to be affixed on the product. But if that is not possible, then we are allowed to affix it on the packaging material or the data plate of the product.

Hence, it is clear that CE Marking is a key indicator of product compliance in European countries.

Self-assessment or a notified body?

What is the Declaration of Conformity (DOC)?

Not all products are supposed to have a CE Marking but directives applicable to certain products decide the requirement of a CE Marking. The risk level is very important to decide whether the application of the certification should be done through a notified body or through self-assessment.

A Notified body is an organization designated by the European Union to assess the conformity of the product and issue the certification before being placed in the market. The notified bodies are referred to as NANDO (New Approach Notified and Designated Association). These organisations would be providing the recognition number to the certificate holder for the product.

The Company can self-declare the conformity after a discussion with qualified experts who would guide them on the requirement of a self-declaration or NANDO. 

What is a directive?

A directive is a rule or regulation applicable to a sectoral reference that is made to the product by categorizing it. The Directive is meant to define the rules and regulation that needs to be followed by the manufacturer and adhere to the requirement of safety, health and environment factors. As the name suggests, it provides us the direction that we need to follow for a product.

Harmonized Standards in CE Marking

The elaboration of the rules and regulation that is applicable for a product is classified as harmonized standard. It provides the basic requirements that a directive would have laid down for the product based on the sectoral classification of the product. Compliance with harmonized standards provides a presumption of conformity with the corresponding requirements of harmonization legislation. Manufacturers, other economic operators or conformity assessment bodies can use harmonised standards to demonstrate that products, services or processes comply with the relevant EU legislations.

Important directives in CE Marking

Medical Device Directive (MDD) – 93/42/EEC

Medical Device Directive is intended to harmonize the laws related to medical devices within the EU. The MD Directive is a ‘New Approach’ Directive for a manufacturer to legally place a medical device in the European market ensuring that the requirements of the MD Directive are met. Manufacturer’s products meeting the harmonised standards have a presumption of conformity to the Directive. Products conforming to the MD Directive must have a CE Mark applied.

Please take the assistance of experts in category classification and identification in medical devices. The Test Report file for the medical device must have all the required details of the device and expert assistance is required for the same.

PPE Directive – 2016/245/EU

Personal Protective Equipment Directive (89/686/EEC) is replaced by a Regulation (EU) 2016/425 applicable from 21 April 2018. It covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation. The manufacturers or their authorised representative in the EU must comply with the essential health and safety requirements of the PPE regulation, directly or by using harmonised European standards.

Measuring Instrument Directive – 2014/32/EU

The Measuring Instruments Directive (MID) is a European CE-Directive that outlines safety requirements for all measuring instruments sold within the EU. The Directive sets standards for both measuring instruments and software. The Measuring Instruments Directive (MID) applies to a wide range of measuring instruments. The purpose of this directive is to create a single market for measuring instruments within the EU. 

Packaging and Packaging Waste Directive – 94/62/EC

Directive 94/62/EC contains updated measures designed to:

• prevent the production of packaging waste, and
• promote the reuse, recycling and other forms of recovering of packaging waste, instead of its final disposal, thus contributing to minimizing the environmental impact of packaging.

Manufacturers must take measures, such as national programmes, incentives through extended producer responsibility schemes and other economic instruments, to prevent and follow the guidelines in regard to the packaging specifically of PPEs and Medical devices that are vastly in use in EU Countries.

Machinery Directive (MD) – 2006/42/EC

It is a European Union Directive concerning certain parts and applications of the Machinery. Its main intent is to ensure a common safety level in machinery placed in the market or put in service across all the countries of the EU and to ensure free movement within the European Union by stating that member states shall not prohibit, restrict or impede the placing on the market and/or by putting into service in their territory which complies with the directive.

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

The Low Voltage Directive (LVD) (2014/35/EU) ensures that electrical equipments within certain voltage limits provide a high level of protection for European citizens and benefits fully from the single market. It has been applicable since 20 April 2016. National authorities are responsible for implementing and enforcing the LVD – this is because they transpose the provisions of EU directives into their own national legislation.

RoHS Directive – 2011/65/EU

RoHS stands for ‘Restriction of Hazardous Substances’. It is one of the CE Marking directives that is most sought out by manufacturers as this directive applies to major products that are intended for daily use. The RoHS Directive is a CE Marking Directive. This means that equipment within its scope must carry a CE Marking if it is offered for sale or placed in the market in the EU.  The CE Marking is applied by the manufacturer (or an Authorized Representative, if mandated) on the product. All CE Marking Directives either indicate the parameters for the marking or direct the reader to Annex II of Regulation no. 765/2008/EC.

Electromagnetic Compatibility Directive (EMC) – 2014/30/EU

The EMC directive limits the electromagnetic emissions from an equipment in order to ensure that the equipment does not disturb radio and telecommunications as well as other equipments. The directive also governs the immunity of such equipments to interference and seeks to ensure that this equipment is not disturbed by radio emissions when used as intended.

The main objectives of the directives are to regulate the compatibility of the equipment regarding EMC:

• Equipment (apparatus and fixed installations) needs to comply with EMC requirements when it is placed on the market and/or taken into service.
• The application of good engineering practice is required for fixed installations, with the possibility that competent authorities of EU countries may impose measures in instances of non-compliance.

How much does a CE Mark Certification cost?

There are so many variables that can impact the price you pay. You don’t buy a CE Marking by the dollar. The price of a CE certification can differ greatly from one product to another. We have seen prices range from $ 500 to even $ 50000. The price is often affected by which certification procedure applies to which product, whether the company can do some or all of the conformity assessments themselves, the level of support needed to prepare the required compliance documents, Technical File, user’s manual and product labelling etc.

Which 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 can the correct CE Marking directive or directives (yes, a product can be covered by more than one CE directive at the same time) and the European harmonized standards along with the certification procedure be accurately 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 many aspects that we have to keep in mind.