Understanding When a CE Certificate Is Not Required

Many people often wonder, “When is a CE certificate not required?” This question arises frequently, especially given the misconceptions surrounding the term “CE certificate.” In reality, there is no standalone “CE certificate” issued by any authority. Instead, there is the CE marking, a symbol that manufacturers apply to products after completing the appropriate conformity assessment procedures. Despite this, many still search for a “CE certificate,” mistakenly believing it to be an official document that authorizes product circulation.

The CE marking is a symbol that manufacturers place on products that meet the requirements of EU directives. It is not a certificate issued by a governmental body but rather a manufacturer’s declaration of conformity with the applicable requirements.

This article clarifies the common misunderstanding about the “CE certificate” and explains the actual process of obtaining CE marking. We will discuss the definition of a machine according to the Machinery Regulation 2023/1230/EU and when a machine must have CE marking. We will also outline the basic procedures for conformity assessment, from self-assessment by the manufacturer to EU type examination involving a notified body. Additionally, we will provide examples of other regulations, such as the Pressure Equipment Directive, where requirements are more stringent. Finally, we will answer the crucial question: when is CE marking not required? We will provide specific examples of situations where a product does not need (and sometimes must not have) CE marking.

“CE Certificate” – Common Term or Formal Document?

The term “CE certificate” has become common in everyday language, but it is imprecise under EU regulations. There is no universal CE certificate issued by an authority that resolves product compliance issues. Instead, there is CE marking – a small logo placed on a product, representing the manufacturer’s declaration that the product meets all applicable EU directive requirements. The manufacturer (or their authorized representative) is responsible for conducting the conformity assessment process and issuing the EU declaration of conformity, a written confirmation that the product meets the requirements. Only then is the CE mark applied to the product.

It is important to emphasize that the “CE certificate” does not appear in official terminology. When someone uses this term, they usually mean the EU declaration of conformity issued by the manufacturer or possibly the EU type examination certificate issued by a notified body in specific cases. Such a type examination certificate confirms that a representative sample of the product has passed independent testing and meets essential requirements – it is required only for selected high-risk products. It is not true that every product needs external certification – in most cases, the manufacturer declares their product’s compliance with the law, and there is no general “CE certificate” issuing body. In other words, CE is a marking, not a document.

Machinery Directive 2023/1230/EU – Definition of a Machine and CE Obligation

One of the key legal acts requiring CE marking is the so-called Machinery Directive (currently in the form of the Regulation of the European Parliament and Council (EU) 2023/1230 of June 14, 2023). It defines essential requirements for machines placed on the EU market. Before discussing when a machine requires CE marking, it is worth understanding the definition of a machine under these regulations. The directive (as per 2006/42/EC, also retained in the new regulation) defines a machine as “an assembly of linked parts or components, at least one of which moves, with a specific application.”

It is important to note that a machine must have a drive other than direct human or animal force – such as an electric, combustion, or hydraulic engine. The definition of machines also includes so-called “complex machines” (combinations of several machines working together as a whole) and safety components for machines (components whose failure threatens safety).

Every machine, as defined by the directive, placed on the market or put into service in the EU must be CE marked, provided it is not subject to other specific regulations or excluded from the directive’s scope. This means that the machine manufacturer has a legal obligation to ensure the product’s compliance with essential requirements (e.g., safety) and conduct a full conformity assessment before the first sale or commissioning of the device. This is confirmed by the EU declaration of conformity attached to the machine, and the compliance is symbolized by the CE mark on the device.

For partly completed machinery, which cannot independently fulfill its function because it is intended for incorporation into another machine or production line, the procedure is slightly different. Partly completed machinery must not be CE marked, as it is not a final product meeting the directive’s requirements. Instead of a declaration of conformity, the manufacturer issues an incorporation declaration and attaches assembly instructions so that the final manufacturer can properly integrate such a part into a complete machine. Only the finished, assembled final machine will be subject to conformity assessment and CE marking. In other words, if you produce a semi-finished product or component that is partly completed machinery, CE is not required at this stage – however, a special procedure and documentation are required under the machinery directive for such cases.

Conformity Assessment Procedures – Self-Assessment vs. Notified Body

The conformity assessment process leading to CE marking can vary depending on the type of machine and the level of risk associated with it. Most often, the manufacturer conducts the conformity assessment themselves – this is the so-called Module A (internal production control), which is the basic procedure for most machines. The manufacturer prepares technical documentation, ensures compliance with essential requirements (often using harmonized standards), and issues the EU declaration of conformity, then applies the CE mark to the machine. In this way, the manufacturer takes full responsibility for the product’s compliance with the law.

In the Machinery Directive 2006/42/EC, Annex IV indicated a group of machines and safety devices with an increased level of risk (including chainsaws for wood, metal presses, fireworks production machines, light curtains). Regulation (EU) 2023/1230 divides these products into two categories in Annex I:

• Part A (IA) – includes selected machines/devices for which conformity assessment with a notified body is always required.
• Part B (IB) – includes other high-risk machines/devices. Here, the manufacturer may conduct the internal production control procedure (without a notified body) provided they fully apply the appropriate harmonized standards covering all essential requirements. If harmonized standards are not fully applied (e.g., due to unusual safeguards, innovations, or lack of standards for a specific solution), the manufacturer must involve a notified body to examine the prototype (EU type examination) or assess the quality management system.

This ensures that higher-risk machines are either designed strictly according to proven standards or verified by an independent body. In practice, for machines from Annex IB (formerly Annex IV in the directive), the manufacturer chooses whether to use full compliance with harmonized standards or apply to a notified body for conformity assessment. However, for Part IA of the new regulation 2023/1230/EU, the involvement of a notified body is always mandatory, regardless of the use of harmonized standards.

A notified body (e.g., an independent research institute with accreditation) conducts the EU type examination – testing and evaluating the machine prototype – or audits the manufacturer’s quality system. After a positive assessment, it issues an EU type examination certificate or approves the quality system, allowing the manufacturer to issue a declaration of conformity and CE mark the product.

In practice, this means that for a typical machine (not subject to specific high-risk machine listings), external certification or involvement of a notified body is not required – a thoroughly conducted internal conformity assessment suffices. However, in strictly defined cases (e.g., listed in Annex IV of the directive), the manufacturer must obtain an independent institution’s opinion. Such a procedure protects users from products that may pose serious risks. It is worth adding that if the manufacturer fully applies harmonized standards covering the requirements for a given high-risk machine, regulations may allow them to use the internal procedure without involving a body (this is an exception provided for certain machines from Annex IV in the current directive). If standards are not applied or do not cover all aspects, type certification by a body becomes mandatory.

Other Directives with Stricter Procedures – Example of Pressure Equipment

For some products, conformity assessment procedures are more stringent from the outset, often regardless of the manufacturer’s decision. An example is the Pressure Equipment Directive PED 2014/68/EU, concerning equipment operating under pressure (e.g., tanks, pipelines, boilers). A key concept in PED is the risk category of the equipment (from I to IV) – the higher the category, the more serious the potential hazard in case of failure. The directive provides that for the lowest category I, the manufacturer can perform the conformity assessment themselves (analogous to Module A – internal production control). However, for higher categories (II, III, IV), more rigorous procedures involving a notified body are required. In practice, this means obtaining a certificate from a notified body – e.g., an EU type examination certificate (Module B) combined with supervised production control (Module C1) or an approved quality system (Module D) for category III/IV equipment.

This approach ensures that equipment posing significant risks (e.g., explosion or pressure leakage) always undergoes independent verification before being placed on the market. In these cases, the manufacturer has no choice – they must involve a notified body during the product’s conformity assessment. Similar solutions exist in other regulations, such as for personal protective equipment (PPE – where helmets, safety harnesses, etc., require body certification), medical devices (most classes of medical devices require an audit and conformity certificate issued by a notified body), or equipment in explosive zones (ATEX). In all these cases, CE marking is the final confirmation of compliance, but it is preceded by a much more complex process, often ending with the issuance of a conformity certificate by an authorized institution.

When Is CE Marking Not Required?

We now address the fundamental question: when does a product not need CE marking? From the previous sections, it is clear that this depends on whether a product is subject to any EU legal acts requiring CE. A simple rule can be formulated:

• If a product does not fall under any of the new approach directives/regulations – CE marking is neither required nor allowed. The manufacturer has no right to CE mark a product not covered by regulations requiring such marking. For example, ordinary furniture, clothing, or food do not fall under “CE” directives, so they do not bear this mark (instead, they are subject to other regulations).
• If a product is a non-independent component or semi-finished product (does not meet the definition of a finished product subject to a directive) – it is also not CE marked. The previously mentioned partly completed machinery is a good example: it does not independently fulfill its function, so it is not subject to the full machinery directive (only its special provisions) – it does not receive the CE mark. Similarly, various spare parts, raw materials, or elements that are not devices in the sense of the directives do not have CE marking (unless a separate regulation requires it for a specific type of component). Always check whether a product fits the definition of a product covered by specific CE requirements.
• Product intended for use outside the EU market – if a product is not placed on the market within the European Economic Area, the CE marking requirement does not apply. This applies, for example, to machines produced exclusively for export to non-EU countries – different regulations will apply there, and the CE mark is irrelevant. Also, a device made as a hobby for personal use (and not transferred/sold to others on the market) does not formally need to meet CE marking requirements, as it is not “placed on the EU market.” Of course, it is in the user’s interest to ensure it is safe, but this is not legally controlled by the CE system.
• Products covered by other regulations instead of CE directives – some products might seem “subject to CE,” but the legislator has excluded them to separate regulations. For example, military equipment or armaments are subject to other regulations and are not CE marked; transport means (e.g., cars) have their own EU approvals outside the CE system; antique devices or antiques are also not subject to the requirements of new directives. In such cases, the lack of CE marking is normal and legal.

In summary, the CE mark is not required for products not subject to the appropriate directives/regulations. Moreover, as emphasized by the European Commission, it is not allowed to place the CE mark on a product not covered by any “CE system” – it would be misleading marking. Consumers sometimes think that CE is a general quality mark and would like to see it on every product, but in reality, CE applies only to specific products and confirms compliance with specific legal requirements, not general quality.

Not every product must have CE marking – only those covered by EU directives or regulations requiring such marking. The term “CE certificate” has proven to be a mental shortcut: there is no single document issued by an authority that magically authorizes a product on the market. Instead, we have conformity assessment procedures, EU declarations of conformity issued by manufacturers, and in some sectors, type examination certificates issued by notified bodies. It is the manufacturer (or importer) who takes responsibility for ensuring the product meets requirements – and they apply the CE mark to the product as proof of this compliance.

CE marking is mandatory when a product falls under the relevant regulations – without CE, legal sale in the EU is impossible. At the same time, it is not allowed to mark CE unnecessarily on products not covered by these regulations. Therefore, it is crucial to correctly determine whether a product falls within the scope of any new approach directive. If so, the conformity assessment procedure must be conducted and CE marking applied. If not, the product is placed on the market without the CE mark (although it must still meet any other applicable regulations, such as general product safety requirements).

Finally, it is worth remembering that the responsibility for correct marking (or its absence) rests with the manufacturer. They declare compliance with the law by issuing the EU declaration and applying CE or not using it when not required. Understanding that the “CE certificate” is a myth and the real obligation is to ensure compliance and correct marking helps avoid many misunderstandings. This allows engineers and entrepreneurs to focus on meeting specific requirements for their products – only where necessary – instead of searching for a universal certificate. In short, CE is a tool for protection and the single market, but it is applied only where regulations require it. Not every product needs CE, but every manufacturer should consciously assess whether their product is subject to these requirements – and act according to the law.

FAQ: When is a CE certificate not required?