Machinery Directive 2006/42/EC (MD) Evaluation and Testing
F2 Labs can perform the evaluation and testing required by the Machinery Directive at our facility or yours. We have assisted with the certification of thousands of products for compliance to the European Directives, including the Machinery Directive.
The scope of the Machinery Directive 2006/42/EC is indicated in Article 1:
- machinery
- interchangeable equipment
- safety components
- lifting accessories
- chains, ropes & webbing
- removable mechanical transmission devices
- partly completed machinery
The Machinery Directive is a European law and requires that equipment within its scope is compliant with the applicable technical requirements listed in Annex I. These technical requirements are called the Essential Health and Safety Requirements (EHSR’s).
The first step in compliance with Annex I is to perform a Risk Assessment on the equipment to determine which of the Annex I EHSR’s are applicable to the equipment, and therefore must be met. The process at that point is to prove and document, point-by-point, how the equipment is compliant with the selected EHSR’s or to determine which of the harmonized EN standards are applicable to the equipment, and then to apply those portions of the applicable harmonized standards to the applicable EHSR’s.
This means you have the choice to prove, technically, the compliance of each applicable EHSR or to apply the applicable portion of an applicable harmonized EN standard. The most practical method is to evaluate and test using harmonized EN standards because compliance with these confers the “presumption of conformity,” which is defined in Article 7 of the Machinery Directive. This is what we do and if there is a risk that is not covered by a harmonized EN standard we will address this specifically and technically.
EN ISO 12100:2010 is the sole harmonized Machinery Directive standard for risk assessment for non-explosive atmosphere equipment and is the first step mentioned above. F2 Labs can perform an evaluation on your equipment to EN ISO 12100:2010 and other harmonized EN standards that may apply.
There are three types or classes of EN standards as pertains to the Machinery Directive:
- A-type standards – cover principles common to all machinery; an example is EN ISO 12100:2010
- B-type standards – address specific aspects of machinery safety and safeguards
- C-type standards – product specific. If your product falls under the scope of a C-type EN standard then that standard is applicable
Once your machine has been evaluated, tested (if required), and made compliant the next step is to complete and sign the EC declaration of conformity. This is a one-page document that lists the machine, and specific details about it, plus the EN standards used to evaluate it and the applicable Directives to which you are claiming conformity for the machine. The EC declaration of conformity must accompany each machine sent to the EU and you must retain a copy of each one for ten years. The document must be matched to a specific machine: i.e., serial number. We can prepare the EC declaration of conformity for you.
You are also required to be able to quickly assemble a Technical File that contains the information needed to prove conformity to any Directives that apply to the machine. This file is used by the European authorities to assess the compliance of the machine but you should not send it with your machine to Europe. The requirement is detailed in Annex VII of the Machinery Directive and your customer does not have a right to this file unless you have previously agreed to it. This requirement extends ten years past the date you ship the machine to Europe. We can help you with this and we can securely store it for you also
The Machinery Directive also requires that your EC declaration of conformity lists an address on community soil (the EU) to which the authorities may write in order to make a formal request for the Technical File. This is a responsibility that an Authorized EU Contact may legally assume for you. We offer that service as well.
Please call or email us to discuss your European CE Mark project. We have helped many machinery manufacturers with this process.
Helpful Links:
- Directive 2006/42/EC (PDF)
- Machinery Directive 2006/42/EC Guide (PDF)
- Application guide: ergonomic health and safety requirements
- Directive 2009/127/EC, machinery for pesticide application
- Regulation (EU) No. 167/2013 for the market surveillance of agricultural and forestry vehicles
- Changes to Machinery Directive Blog Article
Frequently Asked Questions
What is the Machinery Directive 2006/42/EC?
The Machinery Directive 2006/42/EC is a European law that specifies safety
requirements for machinery, interchangeable equipment, safety components,
lifting accessories, chains, ropes, webbing, removable mechanical transmission
devices, and partly completed machinery. Its goal is to ensure machinery safety
within the European Economic Area (EEA).
What Does Compliance with the Machinery Directive
Involve?
Compliance involves ensuring that equipment within the scope
of the Directive meets the applicable technical requirements listed in Annex I,
known as the Essential Health and Safety Requirements (EHSR’s). This includes
performing a risk assessment and documenting compliance with EHSR’s or applying harmonized EN standards.
What is the Role of Risk Assessment in Machinery
Directive Compliance?
The first step towards compliance is performing a
risk assessment to determine which EHSR’s from Annex I apply to the equipment.
This assessment helps identify the specific safety requirements that need to be
addressed.
How Can Harmonized EN Standards Facilitate
Compliance?
Using harmonized EN standards is the most practical method
for demonstrating compliance because these standards confer the “presumption of
conformity” with the EHSR’s. Compliance with these standards simplifies the
process of proving that machinery meets the Directive’s requirements.
What are A-type, B-type, and C-type EN Standards?
A-type standards cover common principles for all machinery (e.g., EN ISO
12100:2010), B-type standards address specific safety aspects and safeguards,
and C-type standards are product-specific, detailing requirements for
particular machinery types.
What is Required After Machinery Evaluation and
Testing?
After evaluation and testing, an EU Declaration of Conformity
must be completed and signed, indicating that the machinery complies with the
Directive and listing the EN standards used for evaluation. This declaration
must accompany each machine sent to the EU.
What is the Technical File, and Who Needs Access to
It?
The Technical File contains documentation needed to prove
conformity with the Directive. It’s intended for European authorities’
assessment of compliance and should not be sent with the machinery. However,
manufacturers must be prepared to assemble and present this file upon request.
Is an Authorized EU Contact Required for Machinery
Directive Compliance?
Yes, the EC Declaration of Conformity must list
an EU-based address for authorities to request the Technical File. An
Authorized EU Contact can legally assume this responsibility for manufacturers.
Can F2 Labs Assist with Machinery Directive
Compliance?
F2 Labs offers comprehensive services for Machinery
Directive compliance, including risk assessment, evaluation, testing, preparation
of Declaration of Conformity, drafting a Technical File template, and serving as an
Authorized EU Contact.
