Certification under Directive 2006/42/EC: Machinery

Directive 2006/42/EC (the “Machinery Directive”) lays down the basic safety requirements for machines and mechanical installations placed on the EU market. The conformity project follows a clear logic. First, we determine the applicable requirements and the boundaries of the object, then we carry out a risk assessment and define protective measures, after which we compile the technical file. The final stage is the correct preparation of the declaration of conformity and the affixing of the CE marking. As a result, you have a set of documents and evidence that confidently passes review by partners and surveillance authorities.

What 2006/42/EC regulates and why it matters

The Directive focuses on safety: a machine must be designed and manufactured so that risks are eliminated or reduced to an acceptable level. The manufacturer is responsible for risk assessment, selecting protective measures, preparing instructions, correct marking, and maintaining a technical file. If any element “sags,” it is usually market access that suffers: supply delays, questions from customers, refusal to accept the equipment on site, and questions from surveillance authorities.

It is important to remember that for machinery, other EU requirements often apply as well (electrical safety, EMC, explosive atmospheres, etc.). Therefore, the project almost always starts with a check of the “applicability package.”

Link to download the Directive:
Directive 2006/42/EC – Machinery

Related EU requirements

We check what applies together with Directive 2006/42/EC:

Electromagnetic compatibility EMC

DyreLow-voltage equipment LVD

Explosive atmospheres ATEX

Pressure equipment PED

Restriction of hazardous substances ROHS

Chemical requirements REACH

After that, we define which requirements are covered by harmonized standards, which by calculations/testing, and where a separate design or documentation solution is needed.

Scope: what is considered a “machine”

Products covered by Directive 2006/42/EC include assemblies of linked parts and components intended to perform a specific function, equipped with a drive system, and having at least one moving part. In practice, this means that a wide range of machines and mechanical systems may fall under the Directive, so at the outset it is important to define the intended purpose, composition, and supply configuration precisely.

The Machinery Directive applies, in particular, to the following categories of products:

• machines and mechanisms;
• interchangeable equipment;
• safety components;
• lifting accessories;
• chains, ropes, and webs;
• removable mechanical transmission devices;
• partly completed machines and mechanisms.

Exclusions and “borderline cases”

There are categories that are explicitly excluded from 2006/42/EC or governed by special acts. Therefore, we always clarify the intended purpose, operating modes, operating environment, energy sources, level of automation, and scope of supply. This helps avoid a typical mistake: “it looks like a machine, so it must be 2006/42/EC” – and later it turns out that some requirements are covered by another regulation or a different conformity assessment route is needed.

Procedura oceny zgodności – jak dobrać ścieżkę

The choice of route depends on the type of machine and equipment, the risks, the scope of supply, and whether a Notified Body is required. A mistake at this stage is costly: you may do “a lot of work,” but according to the wrong logic, and then have to redo documents or tests.

When self-assessment is possible

In many cases, the manufacturer can carry out the conformity assessment independently if the equipment does not fall into categories where a mandatory third party is required. But “independently” means that you are still obliged to have a correct technical file, risk assessment, instructions, marking, and declaration. And it is these materials that customers and inspectors most often ask about.

When a Notified Body is required

The involvement of a Notified Body is required in situations where the rules of the Directive provide for external assessment or verification of certain solutions/categories. We identify in advance what exactly the third party will assess, what evidence is needed, and how to prepare the package so that you do not “run into” formal nonconformities at the end of the project.

Transition to the new regulation: what to consider in advance

The Machinery Directive 2006/42/EC is gradually being replaced by Regulation (EU) 2023/1230. This affects how safety and conformity materials are prepared and provided, and it also strengthens requirements for manageability of documentation throughout the product life cycle. Therefore, it makes sense to prepare in advance a process for updating files and instructions, establish version and configuration control, ensure traceability between the supply and the evidence base, and check whether the equipment falls into higher-risk categories and what the confirmation route will look like. This approach helps you get through the transition without stopping supplies and without emergency reworking of documentation.

Our service: turnkey certification

We first determine applicability and boundaries, then address the risks and collect the evidence, after which we bring the package to a correct declaration and CE marking. If the manufacturer does not have a legal presence in the EU, we help arrange an official representative for the project. To keep the work transparent, at the start you receive a clear list of input data, an initial indication of the route, and the structure of the future file.