CE Marking Exemptions: What Qualifies, and What Doesn’t
Real exemptions from CE marking exist, and almost none of them removes the CE mark from a product entirely. Each one is written into a single directive or regulation, applies only inside that piece of legislation, and leaves every other applicable rule untouched.
That distinction decides most real cases. A product can fall outside the EMC Directive and still require the CE mark under the Low Voltage Directive. A machine can escape RoHS and still need a full technical file under the Machinery Regulation. The question worth asking is never whether a product is exempt, it’s which specific obligation a specific provision lifts, and what stays behind.
The word itself causes half the confusion, so it’s worth pinning down before looking at any individual provision.
What “exemption” actually means in CE marking
Three separate mechanisms travel under the same word.
The first is a scope exclusion. The directive lists product categories it does not cover, usually because more specific legislation handles them. These sit in Article 1 or 2 of the legal text, or in a dedicated annex.
The second is a conditional derogation. The product sits squarely inside the scope, and a specific provision suspends the obligation as long as certain conditions hold. Trade fair displays work this way.
The third applies to substances rather than products, and only RoHS uses it. Specific applications of a restricted substance get a time-limited authorization that has to be renewed.
No horizontal EU law grants exemptions across the whole CE markingsystem. Regulation 765/2008 and Decision 768/2008 set the common framework of definitions, conformity assessment modules and marking rules, and neither creates a single exemption.
Every exemption lives inside one directive and stops at its edge.
Exclusions written into the scope of each directive
Article 1(2) of the Machinery Directive 2006/42/EC excludes means of transport by air, water and rail, seagoing vessels, machinery designed for military or police purposes, and several other categories.
Article 2(2) of the Machinery Regulation 2023/1230 replaces that list from 20 January 2027, and it runs longer. The Regulation does not apply to safety components supplied by the original manufacturer as spare parts to replace identical components, equipment for fairgrounds and amusement parks, machinery designed for or used in nuclear installations where compliance could undermine nuclear safety, weapons including firearms, means of transport by air, water and rail, aeronautical products covered by Regulation 2018/1139, motor vehicles, two and three-wheel vehicles, quadricycles and agricultural and forestry tractors covered by their own type-approval regulations, vehicles built exclusively for competition, seagoing vessels and mobile offshore units, machinery for military or police purposes, machinery built for research and temporary laboratory use, mine winding gear, and machinery used to move performers during artistic performances.
Two further groups of electrical products sit outside the Regulation. Certain items fall out where the LVD or the RED covers them, including household appliances for domestic use, audio and video equipment, IT equipment, ordinary office machinery, low-voltage switchgear and control gear, and electric motors. High-voltage switchgear, control gear and transformers are excluded outright.
Read those two groups closely, because the Regulation narrowed them. Ordinary office machinery stays outside, with additive printing machinery for producing three-dimensional products carved out of the exclusion, which brings 3D printers into scope. The household appliance exclusion now reads “which are not electrically operated furniture”, so electrically operated furniture falls inside the Regulation as well.
Annex II of the Low Voltage Directive excludes electrical equipment for explosive atmospheres, equipment for radiology and medical purposes, electricity meters, domestic plugs and socket outlets, electric fence controllers, and specialised equipment for ships, aircraft and railways that follows international safety provisions. The LVD also sets voltage limits, so equipment operating below 50 V AC or 75 V DC falls outside its scope on that basis alone.
Most of these exist because another piece of legislation covers the product more specifically. Equipment for explosive atmospheres goes to ATEX. Medical equipment goes to its own regulation. The exclusion redirects the product, it rarely releases it.
These lists are not interchangeable. An exclusion in the LVD says nothing about the Machinery Regulation, and a manufacturer who finds their product in one annex still has to check every other directive that could apply.
Exemptions that apply under conditions, not by product type
The same derogation often appears in several directives with nearly identical wording, which makes it look horizontal. Each copy is valid only within its own legislation.
Trade fairs, exhibitions and demonstrations
The Machinery Regulation, the EMC Directive and the Low Voltage Directive all allow non-compliant products to be displayed at trade fairs and similar events. The conditions are consistent across the three: a visible sign has to state clearly that the product does not comply and will not be made available on the market until it does, and adequate protective measures apply during any live demonstration.
What each directive protects differs. The Machinery Regulation requires measures to protect persons. The EMC Directive requires measures to avoid electromagnetic disturbance.
The derogation covers display and demonstration. Selling the unit off the stand, taking orders for delivery, or handing it to a customer at the end of the show all fall outside it.
Is there an exemption for research and development equipment?
Four pieces of legislation address R&D, and all four say something different.
The Machinery Directive excludes machinery specially designed and constructed for research purposes for temporary use in laboratories, in Article 1(2)(h). The Machinery Regulation keeps the same exclusion. Everything rests on “temporary”: once the use becomes permanent, the exclusion falls away and the machine enters scope.
The Low Voltage Directive, the EMC Directive and the Radio Equipment Directive all exclude custom-built evaluation kits destined for professionals to be used solely at research and development facilities. The wording is almost identical in the three, sitting in Annex II of the LVD, in the scope exclusions of the EMC Directive, and in point 4 of Annex I of the RED.
RoHS takes a different route again. Article 2(4)(j) excludes equipment specifically designed solely for research and development purposes and made available only on a business-to-business basis. This one covers complete equipment rather than development boards, and it hangs on the sales channel.
A single laboratory instrument can therefore sit outside RoHS under the B2B research exclusion and still fall inside the LVD, because the LVD exclusion requires something much narrower.
The custom-built evaluation kit exemption, and why most products don’t qualify
The official LVD guidelines treat the evaluation kit exclusion as cumulative.
A product qualifies only where every element holds at once: custom-built, an evaluation kit, destined for professionals, used solely at research and development facilities, and used there for research and development purposes. Meeting four out of five leaves the product in scope.
The guidelines also define what counts as an evaluation kit, and the definition is narrow. It describes a printed circuit board carrying an integrated circuit and supporting components, assembled into a working circuit for evaluation and development work. A finished product does not fit that description, regardless of who buys it or where it ends up.
“Custom-built” carries its own misunderstanding. It points to highly specialised development work, typically collaborative and documented as such. A catalogue product with configurable options does not become custom-built because the customer picked the options.
A finished instrument sold to research laboratories is a finished product placed on the market. Work equipment used by employees attracts national workplace legislation on top of the product rules, which in practice means employers across the EU are required to provide CE marked equipment to their staff.
Exemptions under the EMC Directive
The EMC Directive carries two exemptions that come up constantly in industrial projects, and both illustrate the same principle: what decides them is how the product reaches the market, not what the product is. Neither one removes CE marking. The EMC Directive governs electromagnetic compatibility and nothing else, so a product released from EMC obligations usually still carries the CE mark under the LVD, the Machinery Regulation, RoHS or all three.
The first covers components supplied only to professional integrators. The EMC Directive defines apparatus as a finished appliance made available on the market as a single functional unit and intended for the end user, so a component or sub-assembly supplied only to professional assemblers for incorporation into their own products, and never made available to end users, falls outside that definition. Internal power supplies and print units built into computers and printers are the standard examples. The exemption tracks the channel rather than the hardware, and the same module sold separately as a spare part or listed for retail becomes apparatus under the full EMC regime.
The second covers apparatus built for one specific fixed installation. A fixed installation is a combination of apparatus assembled and intended for permanent use at a predefined location, such as an industrial plant, a power station or a building electrical system, and it never gets placed on the market, so Article 19 asks for good engineering practice documented by a named responsible person instead of CE marking and a Declaration of Conformity. Article 19 also relieves apparatus built for one such installation and not otherwise made available on the market from the conformity assessment, CE marking and documentation obligations, provided the accompanying documentation identifies the installation, its electromagnetic compatibility characteristics and the precautions for incorporating the apparatus without compromising the conformity of the whole. Size and permanence alone do not qualify: an industrial machine bolted to a factory floor remains apparatus and needs full CE marking.
Large installations that cannot be measured in a laboratory
Difficulty of testing has never been a legal ground for exemption. Where measurement gets impractical, what changes is the form the evidence takes.
For a fixed installation, no test campaign applies at all. The good engineering practice route replaces laboratory reports with documented design and installation decisions: correct selection of CE marked components, respect for the manufacturer information on intended use, cable routing, segregation, bonding and earthing.
For large apparatus, the standards themselves provide the answer. EN 55011 allows in-situ measurement of class A equipment in groups 1 and 2, precisely so that industrial equipment that cannot travel to a chamber can still be measured at its installation site. The generic immunity standards for industrial environments work the same way.
Where harmonised standards cannot be applied in full, the EMC Directive accepts an electromagnetic compatibility assessment supported by technical analysis and justification recorded in the technical documentation. The obligation holds, the evidence takes a different form.
What is not an exemption, even though manufacturers assume it is
Five situations get treated as exemptions regularly, and none of them is one.
One-off and custom production. No directive sets a quantity threshold. A machine built once against a customer specification gets placed on the market exactly as a production run of a thousand does, and needs the same technical file, Declaration of Conformity and CE mark. Internal production control applies to a single unit without modification. The overlap with “custom-built evaluation kits” is a coincidence of vocabulary, nothing more.
Machinery built for your own use. The Machinery Directive defines the manufacturer as the person who designs or manufactures machinery and is responsible for its conformity, whether that is with a view to placing it on the market, under their own name or trademark, or for their own use. A company building a machine or a production line for its own factory is the manufacturer and carries every obligation in Article 5. Nothing gets placed on the market here, and the trigger is putting into service, which means the first use of the machinery for its intended purpose in the EU.
Small companies and low volumes. EU harmonisation legislation on CE marking contains no carve-out based on headcount, turnover or units sold. Other areas of EU law do scale obligations by company size, which is where the assumption usually comes from.
Partly completed machinery. This is a parallel regime rather than an exemption. An assembly that is almost machinery and cannot perform a specific application on its own, such as a drive system, carries a Declaration of Incorporation, assembly instructions and its own technical documentation, and the integrator who builds it into the final machine takes responsibility for the result. Two traps follow. Labelling a functional machine as partly completed to avoid the mark fails on inspection, and partly completed machinery can still fall under other directives that require CE marking in their own right.
Spare parts. An identical replacement part supplied to replace a defective component in an existing machine relies on the original conformity. The Machinery Regulation states this directly for one case, excluding safety components supplied by the original manufacturer as spare parts to replace identical components. The boundary sits in three places: a part that is a product in its own right under a directive, such as a power supply, needs its own mark; a part sold for use across different machines is a product in its own right; and a part that changes performance or function stops being a replacement and becomes a modification.
All five rest on the same assumption, that obligations scale with volume, size or commercial arrangement. Placing a product on the market or putting it into service is what triggers CE marking, and quantity plays no part in it.
When an exemption stops applying
An exemption describes a state that has to be maintained, and several of them expire quietly.
Machinery excluded as research equipment for temporary laboratory use loses the exclusion when the use stops being temporary. Equipment outside the EMC Directive because it only reaches professional integrators falls back inside it the day it goes on sale to end users. RoHS substance exemptions carry expiry dates and need renewal applications to the Commission, with existing exemptions staying valid only until the Commission decides on the renewal.
Substantial modification is the sharpest of these. The Machinery Regulation 2023/1230 now defines the concept explicitly, and anyone who substantially modifies machinery already on the market becomes the manufacturer of a new product, with a fresh conformity assessment, technical file, Declaration of Conformity and CE mark to produce.
Most exemption questions turn out to be scope questions underneath. Before asking whether a provision releases a product from an obligation, the useful exercise is establishing which directives cover it in the first place, because that determines which exemptions are even available and what remains once one of them applies.
If you want that mapped out properly before committing to testing or documentation, get a quoteand we’ll work out exactly which directives cover your product and where it stands against each of them.
