The most fundamental — and most consequential — mistake made in the CE process is incorrectly or incompletely determining which EU directives apply to a product. Many manufacturers focus on a single directive (usually the best-known one) and overlook the others; yet the vast majority of modern products fall under more than one directive at once. In this article we explain how to systematically determine which directives apply to your product, how to manage overlapping scope, and the common mistakes made at this stage.
The Method for Correctly Determining Directive Scope
The EU's CE marking system is not a single law — it is made up of a series of sector-specific directives and regulations known as the "New Approach" and the "New Legislative Framework." Each directive has its own "scope" clause and, usually, an "exclusions" list as well. Determining scope means comparing these clauses, line by line, against your product's technical characteristics; deciding based on general impression or sector habit is risky.
A correct scope analysis starts with four core questions: What is the product's main function? What kind of energy source does it run on? Does the product have moving/mechanical elements? Does the product involve wireless communication, hazardous substances, or a special use environment (explosive atmosphere, medical use, operating under pressure)? The answers to these questions largely determine which family of directives comes into play.
Mechanical and Electrical Assessment
Products with moving parts, driven by a drive system, and performing a function without (or with only partial) human intervention generally fall under the Machinery Directive 2006/42/EC; this directive will be progressively replaced by Machinery Regulation (EU) 2023/1230 from 20 January 2027. Products that run on electricity within a specific voltage range (approximately 50-1000V AC / 75-1500V DC) fall under the Low Voltage Directive (LVD) 2014/35/EU. An important nuance: if electrical equipment is also part of a machine, its electrical safety requirements are often handled within the Machinery Directive's general risk assessment framework, and the overlap with LVD should be assessed based on the product's primary function. In such borderline cases, documenting the rationale for the decision in writing is very important.
Wireless Communication and the Radio Equipment Directive
If the product contains a component that intentionally transmits or receives radio frequency signals — Bluetooth, Wi-Fi, LoRa, RFID, etc. — the Radio Equipment Directive (RED) 2014/53/EU applies. For products under RED, electrical safety requirements are usually met within RED's own framework (via delegated standards); this is why simplifications such as "we have a wireless module, so RED alone is enough" — or, conversely, "the wireless module is small, so it's negligible" — should be avoided.
Hazardous Substances and Sector-Specific Regimes
The RoHS Directive 2011/65/EU, which restricts the use of certain substances such as lead, mercury and cadmium in electrical and electronic equipment, should also be assessed for almost every electronic product within scope. Beyond this, if your product will be used in an explosive atmosphere, ATEX legislation applies; if it is personal protective equipment, the PPE Regulation applies; if it is for medical use, the Medical Device Regulation (MDR) applies; if it operates under pressure, the Pressure Equipment Directive (PED) applies — entirely separate, and sometimes far stricter, regimes. These sector-specific regulations are often overlooked in a standard scope scan, because they are assessed not under the "general CE" heading but under their own dedicated legislation.
Overlapping Directives and Priority Order
Where more than one directive applies at the same time, the question "which one comes first" is the wrong framing; the correct approach is that each directive's essential requirements must be met separately. For example, for a production machine with a wireless control panel, the Machinery Directive covers mechanical and general safety, RED covers wireless communication along with related electrical safety elements, and RoHS covers substance restrictions in the electronic components. A separate conformity assessment is carried out for each of these directives, but ultimately all applicable directives are referenced together in a single EU Declaration of Conformity.
The Practical Consequences of Getting Scope Wrong
The most common consequence of an incomplete scope analysis is that the technical file and testing were prepared for only one directive. If a missing directive is identified during a market surveillance inspection or an importer's pre-check, the product can be recalled, sales can be suspended, or the CE marking can be considered invalid. At that point, retroactively completing tests and documentation is far more costly and time-consuming than a process planned correctly from the start.
Relevant Directives and Standards
The table below summarizes the general application criteria for the directives most commonly encountered when determining CE scope. The final decision for each product should always be made by reviewing the scope and exclusion clauses in the directive's full text.
| Directive / Regulation | General Scope | Application Criterion |
|---|---|---|
| Machinery Directive 2006/42/EC (to be replaced by Machinery Regulation (EU) 2023/1230 from 20 January 2027) | Machinery with moving parts, partly completed machinery and related equipment | Mechanical hazard, drive system |
| Low Voltage Directive (LVD) 2014/35/EU | Electrical equipment | Approximately 50-1000V AC / 75-1500V DC |
| Radio Equipment Directive (RED) 2014/53/EU | Radio equipment | Intentional radio frequency transmission/reception |
| RoHS Directive 2011/65/EU | Electrical/electronic equipment | Restriction of certain hazardous substances |
Step by Step
- Clearly write down the product's technical definition, main function and intended use.
- Determine the product's energy source, voltage range, and any moving/mechanical elements.
- Scan the official scope and exclusion clauses of every potentially relevant directive, one by one.
- Separately assess the product for wireless communication, hazardous substance content and any special use environment (explosive atmosphere, pressure, medical use).
- Identify where more than one directive overlaps and build a separate requirements list for each.
- Determine the harmonized standards applicable under each directive.
- Document the scope decision reached, together with its rationale, in the technical file.
- Confirm the decision with an independent expert or consultant to eliminate any possible blind spots.
Most Common Mistakes
- Focusing only on the best-known directive and never scanning other possible scopes.
- Reducing RED scope to just "is there a wireless connection?" and skipping the associated electrical safety requirements.
- Automatically assuming a product is out of scope without reading the exclusion clauses.
- Treating partly completed machinery as a full machine and choosing the wrong declaration type.
- Not reassessing scope after a software update or hardware revision.
- Leaving sector-specific regulations (PPE, medical devices, pressure equipment, ATEX) out of the general CE scan.
- Fully delegating scope-determination responsibility to the importer or distributor.
Frequently Asked Questions
Can more than one EU directive apply to a product at the same time?
Yes, this is the rule rather than the exception. For example, a machine driven by an electric motor and controlled by a wireless remote can fall under the Machinery Directive and the Radio Equipment Directive at once. Each directive's essential requirements must be met separately and referenced together in a single EU Declaration of Conformity.
Should scope be reassessed when the product design changes?
Yes. Adding a new communication module, a different power source, or an additional function can change the scope. Every significant design revision requires re-checking which directives still apply and whether a new directive has come into play.
Can an accessory or spare part fall under a separate directive too?
Yes, an accessory or spare part placed on the market independently can fall under a different directive based on its own function. If it is sold together with the main product, the scope of the whole applies; if sold separately, the part's own scope applies.
Which directive applies to products containing software?
Software itself is generally not the direct subject of a separate directive, but the safety functions of the hardware the software controls fall under the relevant directive. If there is wireless updating or connectivity, RED and cybersecurity requirements must also be assessed.
If a product is only for export, are EU directives still the basis?
Yes, for any product intended for the EU market, EU directives are the basis. If the target market is outside the EU, that country's own legislation applies; however, since many countries use regulations similar to or referencing the CE process, scope analysis is often a common starting point.
Should documentation be prepared even for a product found to be out of scope?
Even if the conclusion is that a product falls under no directive, keeping a short assessment note explaining the reasoning behind that conclusion is important for proving the reason for being out of scope during a possible market surveillance inspection.
Is the distributor or importer responsible for determining scope?
Determining scope and ensuring conformity is primarily the manufacturer's responsibility; however, the importer and distributor also have an obligation to reasonably check that the product carries the CE marking, the EU Declaration of Conformity and the core documentation.
Is scope determination different for products manufactured outside the EU?
The logic of scope determination is the same — it is based on the product's function, energy source and intended use. The difference is that a non-EU manufacturer generally needs to appoint an authorized representative and ensure the technical file is accessible within the EU.
What are the consequences of determining scope incorrectly?
An incomplete assessment of directives can lead to the CE marking being considered invalid, the product being withdrawn from the market by surveillance authorities, administrative fines, and serious damage to brand reputation. This is why scope analysis is the most critical step of the process.
Which sources are considered official and reliable for determining scope?
The core reference sources are the full text of the relevant directive or regulation as published in the Official Journal of the European Union, the European Commission's sector guidance documents, and the scope provisions of harmonized standards.
How does SAFETEST support the scope determination process?
SAFETEST reviews your product's technical characteristics, energy source and use scenarios to clarify all applicable directives and any possible overlaps, documents the decision in a way that can be justified in the technical file, and helps avoid unnecessary test/certification costs.
Conclusion
Correctly determining directive scope is the foundation the entire CE process is built on. Assessing your product's function, energy source, communication features and use environment holistically — rather than focusing on a single directive — prevents both unnecessary costs and market surveillance risk. Documenting the scope decision in writing, with its rationale, also creates a secure reference point for later stages of the process.
If you're not sure which directives apply to your product, explore our CE consultancy service or get in touch with us directly to determine the correct scope at the start of the process.
Get a Free Pre-Assessment