CE certification is a common name for the process aimed at assessing the product’s compliance with the New Approach legislation. The CE mark must be affixed to a product in order for the product to be allowed to be introduced into the European Economic Area. The granting of such a marking is preceded by thorough testing and preparation of appropriate documentation and declaration of compliance with current directives.

Note: In the formal proceedings, instead of specifying the CE certification, the names of the EU Declaration of Conformity or the EC Declaration of Conformity are used – depending on the directive the given product is assigned under.

CE marking – marking

We provide professional advice and comprehensive assistance in carrying out the entire CE certification process . Our services include:

  1. Assessment of potential hazards of the product or the method of its production (required by EU regulations).
  2. Identification of compliance with EU directives required for CE marking.
  3. Preparation of a list of legal and normative requirements that are necessary for CE marking.
  4. Preparation of a diagram of technical documentation, template of the instruction manual , warranty card and information on the packaging .
  5. Controlling research processes.
  6. Development of model CE declaration of compliance and model nameplate.
  7. Full support as a representative in the process of obtaining relevant tests, certificates and permits.

Which products are subject to CE marking according to applicable directives and regulations?

  • Electrical and electronic equipment,
  • Personal protective equipment PPE,
  • machines,
  • radio equipment,
  • toys,
  • fireworks and explosives for civilian use,
  • pressure products,
  • simple pressure tanks,
  • boats and yachts,
  • line equipment/devices,
  • measuring devices,
  • Non-automatic weighing devices,
  • appliances burning gaseous fuels,
  • elevators,
  • in vitro diagnostic devices,
  • medical equipment,
  • active implantable medical devices,
  • construction products,
  • Water heating boilers,
  • appliances operating in potentially explosive atmospheres ATX.

WHAT IS THE PURPOSE OF THE CE CERTIFICATE?

The use of CE certification was introduced to enable the free movement of goods within the EU Member States. If a product has the CE marking, countries within the EU cannot prohibit its introduction on their market. However, when a product is covered by at least one New Approach Directive and yet has no CE marking, it is prohibited to sell and use within the EU.

The primary purpose of CE certification is to protect the rights of consumers and workers and to eliminate unfair competition.

WHO CAN APPLY THE CE MARK TO THEIR PRODUCT OR PACKAGING?

The decision to affix the CE marking to a product is made by its manufacturer. This is synonymous with declaring that the product, which is placed on the free-trade zone market, meets the essential requirements of directives concerning it. For this purpose, it is necessary to obtain a positive assessment of compliance with the applicable regulations.

How to assess the product’s compliance with the New Approach directives?

You can do it independently -in that case the whole process is conducted by the manufacturer or their representative.

The second option is to have the product assessed by an independent third party – a notified laboratory or a notified certification/control entity. In some cases, this is required from top-down. However, it must be noted that an independent body does not grant the CE marking. Its role is only to assess the compliance with the Directive requirements and issue a document confirming it.

WHAT PRODUCTS REQUIRE INSPECTION BY A NOTIFIED ENTITY?

Independent third-party assessment is not required for each product – usually such verification can be done by yourself. However, for some product categories, the regulations require the manufacturer to test the product by a notified entity (the relevant entity can be found in the Nando database). This is an organisation designated by the national authorities to carry out tasks resulting from the directives. Manufacturers may choose between Notified Bodies located throughout the European Union.

  • If the product does not have to undergo an independent third-party assessment, it is the manufacturer’s responsibility to verify its compliance with the technical requirements of the directives. In this case, the manufacturer prepares detailed documentation taking into account, the potential users’ risks.
  • When a product is assessed by a notified body, the CE marking must be preceded by the entity’s identification number. Both elements should be arranged in a way that indicates that they are connected.

THE CE MARKING DOES NOT APPLY IF THE PRODUCT IN QUESTION:

  • does not belong to any category within the New Approach directives.
  • It will be placed on markets outside the European Economic Area.
  • belongs to one of the 3 product categories: Trans-European high-speed rail system; Trans-European conventional rail system; packaging and packaging waste.

HOW TO ISSUE A CE CERTIFICATE – STEP BY STEP

The process of obtaining a CE certification is divided into several stages. The whole process consists of analysing the product in terms of the EU requirements – it is the manufacturer’s duty to check whether their product complies with the specified directives. Both the test’s run and results must be documented.

WHAT IS PRODUCT COMPLIANCE ASSESSMENT?

  • It is performed by the manufacturer themselves or an authorised representative.
  • During the analysis a sequence of procedures defined by the New Approach provisions are carried out.
  • Any sequence of so-called modules is selected to perform the procedure (usually identified by capital letters). Information on the available module combinations can be found in the product-specific directives.

The conformity assessment of some products requires the participation of a third party, the so-called notified entity.

What is the presumption of conformity in the CE marking?

The recognition that a product meets the national standards’s requirements including harmonised standards are also compliant with the basic requirements. When the manufacturer doesn’t apply the harmonised standard fully or only partially, they are obliged to document the conformity of the product with the essential directives and the activities they have undertaken to meet these requirements.

Stages of the CE certification process

  1. Selection of appropriate directives – i.e. regulations specifying the essential requirements that a product must meet in order to obtain the CE marking. This is done by checking which directives have been assigned to a given product (each product is covered by specific rules of conduct);
  2. Selection of the conformity assessment procedure module – in the directives there are modules of product conformity procedures, marked with letters A to H. Before launching a product on the market, each product undergoes such a procedure, in accordance with the assigned directive. The manufacturer themselves decides on the choice of procedure;
  3. The use of harmonised standards – these are optional, detailed requirements for a given product. They complement New Approach directives’ essential requirements. The manufacturer selects them from among the standards assigned to a particular product. Harmonised standards can be very helpful, because in many cases they facilitate the procedure transition – their application may result in a presumption of conformity with the essential standards. In some cases they also allow avoiding the necessity of testing the product by a notified entity. An updated list of standards is available at www.pkn.pl;
  4. Product risk analysis – the manufacturer is obliged to check what risks are generated by their product (according to the applicable standards). This enables the introduction of appropriate security measures, minimising any potential risk. Although not every directive requires the manufacturer to document such an analysis, it is worth to enclosing the results;
  5. Optionally – adjusting the product or production process to the applicable regulations – if tests and analyses show that the product does not meet the directives’ standards, it must be adjusted to them – this may apply to the product as a whole, its part or production process;
  6. Preparation of technical documentation in the CE certification process – after analysing and introducing possible changes, it is necessary to prepare the product technical documentation, which contains the confirmation of compliance with the New Approach directives. The manufacturer must complete the technical documentation. This can be done with the assistance of an appropriate consulting company (e.g. as part of our legal services);
  7. Preparation of the declaration of product compliance with the directive requirements – once again it is a document prepared by the manufacturer or their appointed representative. Such a letter allows us to presume that a number of requirements have been met, to guarantee high quality and product safety. By signing the compliance declaration, the manufacturer certifies the product’s compliance with the basic requirements, and then stores it together with the technical documentation for 10 years;
  8. Marking the product with the CE mark – passing the above mentioned stages entitles the product to be branded with the CE mark. The manufacturer is responsible for the marking – the CE must be affixed to each piece of the product in a permanent, non-removable and legible form, with a minimum size of 5 mm.

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