Ensuring Compliance with Highest Safety and Quality Standards

As an integral part of our service offering, we offer specialized expertise in specific aspects of the machine or process. This allows us to contribute significantly to the success of our customers' projects. To provide transparency and assurance, we issue a Declaration II 1A or II 1B, tailored to each project's requirements. This declaration serves as a comprehensive compliance statement, clearly defining the extent of our involvement and the meticulous adherence to industry norms and standards.

At Goodtech, we take great pride in our ability to support machine builders in achieving their CE marking goals, ensuring their production lines meet stringent regulatory requirements. With our expertise and commitment to quality, we are your trusted partner for seamless and compliant machinery integration.

Compliance with Machine Regulations in the Workplace

The Machine Regulation requires manufacturers and suppliers of machines used in the workplace to ensure their safety. This regulation applies to all types of machines, whether new or used, and mandates the provision of satisfactory information regarding their intended use.

CE Marking and Compliance Declaration:

As part of this requirement, the manufacturer or their representative must:

• Apply the CE mark to indicate compliance with all relevant requirements.
• Issue and sign a compliance declaration for the machine.
• Optionally, prepare an assembly declaration.
• Compile information on what has been done and why in technical documentation

The obligation to CE mark and issue a compliance declaration applies to:

• All new machines, regardless of whether they are produced within or outside the EEA.
• Imported used machines from countries outside the EEA.
• Significantly modified machines.
• Assembled machines or production lines consisting of several machines.

What Does CE Marking Mean?

CE marking and the compliance declaration grant the machine, when first introduced to the market, free access to all EU and EFTA countries. CE marking indicates that the manufacturer believes the machine meets the relevant requirements and assumes responsibility for its production. Therefore, the manufacturer's name is accompanied by a valid CE mark.

CE marking is mandatory for all machines produced after January 1, 1995, and sold within the EU and EFTA. Machines manufactured before this date should not bear the CE mark. For machines imported from outside the EU/EFTA, the manufacturer or importer must CE mark and issue a compliance declaration. This applies regardless of the machine's age.

Changes to Machines:

If a machine undergoes significant changes, especially if the power increases or new functions are added, there may be a requirement for a new CE marking, even if the machine predates January 1, 1995. This is because the machine may have acquired new risks after the modification, and therefore needs to be treated as a new machine. In cases where machines are subject to multiple regulations requiring CE marking, the CE marking should indicate compliance with all applicable regulations.

Compliance Declaration:

A compliance declaration is the manufacturer's self-declaration confirming that the machine complies with the requirements of the Machine Regulation. It may also include an explicit statement of compliance with other regulations or relevant provisions. A compliance declaration should include:

1. The name and address of the manufacturer and/or a responsible person.
2. Machine name or designation, model, and serial number for identification.
3. Signature of an authorized person.
4. Standards used in the construction and production of the machine.
5. Regulations/EU directives the machine complies with.

Special Safety Considerations and Assembly Declaration:

For particularly hazardous machines listed in Annex IV of the Machine Regulation, the manufacturer must follow specific procedures for assessing the machine's compliance. This must be completed before the manufacturer delivers the equipment to the user/owner.

An assembly declaration should be issued if a machine is partially completed, meaning it does not function independently but is intended to be:

• Assembled or constructed with another machine, or
• Connected with other machines to form a new machine or machine system, subject to certain conditions.

A complete assembly must be accompanied by a compliance declaration issued by the responsible party for the assembly. In practice, this means the machine should not be used until:

1. The final product is complete.
2. All relevant fundamental health, environmental, and safety requirements are met.
3. The person who performed the final installation or assembly has issued a compliance declaration.

Technical Documentation:

The manufacturer should prepare technical documentation for the machines they produce. This documentation demonstrates how a machine meets the fundamental health, environmental, and safety requirements. The technical documentation should include:

1. Drawings of the machine and its control systems.
2. Information on specifications and standards used in construction.
3. Relevant test results and other data.
4. Technical reports and certificates from other organizations may also be included.

The manufacturer is not obligated to make the contents of the technical documentation available to other suppliers or end-users of the machine.

Relevant Legislation:

1. Machinery Directive, Article 12(2)(b) on the manufacturer's obligation to prepare user instructions.
2. Machine Regulation, Section 11 on CE marking.
3. Machine Regulation, Annex II on requirements for the content of the compliance declaration.
4. Machine Regulation, Annex II on further requirements for the content of the assembly declaration.
5. Machine Regulation, Annex VII on requirements for technical documentation.

CE marking, declaration of conformity, and assembly declaration of machines:

The Machinery Directive requires that those who:

• Produce machines
• Supply machines
• Assemble machines (e.g. into a production line)
• Install machines

To be used in the workplace, ensure that the machines are safe to use. They are then defined as the machine builder, with the requirements and obligations that come with it. The legislation requires the manufacturer/machine builder to provide satisfactory information on the intended use of the machine and equipment. This requirement applies to all types of machines for use in the workplace, whether the machines are new or used.

As part of the process, the manufacturer (machine builder) or their representative should:

• CE mark the machine (production line) to show that the machine complies with all relevant safety requirements defined in the Machinery Directive
• Issue and sign a declaration of conformity for the machine/production line
• Optionally prepare an assembly declaration for the machine
• Collect information on machine safety and what has been done, and why, in technical documentation The obligation to CE mark and declare conformity

The obligation to declare conformity and CE mark machines applies to:

• All new machines regardless of whether they are produced within or outside the EEA
• Imported used machines from countries outside the EEA
• Substantial modification of the machine/production line
• Assembly of multiple machines into a new machine/production line

CE marking

The CE marking, and the declaration of conformity provide "the product" being placed on the market for the first time with free access to all countries in the EU and EFTA. This is the main function of CE marking:

• A machine being CE marked means that the manufacturer believes the machine meets the relevant safety requirements and takes on the responsibility as the producer. Therefore, the name of the manufacturer is displayed along with a valid CE mark.

• All machines manufactured after January 1, 1995, and placed on the EU and EFTA market must be CE marked. Machines older than this date do not need to be CE marked.

• A machine imported from countries outside the EU/EFTA must be CE marked and declared conformity by the manufacturer or importer. This applies regardless of the age of the machine.

• If a machine is modified (a "substantial" modification), especially when the power increases or if the machine receives new functions, there may be a requirement for a new CE marking, even if the machine is from before January 1, 1995 (retrospective effect).

The reason for this is that the machine may have acquired new hazards (e.g. changed behavior) after the modification and therefore needs to be treated as if it were a new machine.

Machinery Directive

• The Machinery Directive consists of 7 chapters. A machine builder must document that the relevant requirements are met.

• The Machinery Directive is "framework-driven". This means that the overarching framework/requirements are defined.

• The requirements of the Machinery Directive are fulfilled by following harmonized standards. If the standard is followed, the requirement of the Machinery Directive is automatically fulfilled.

Principles for the construction of a safe machine Ref. ISO12100

Principle 1: DESIGN

Design out hazards in the machine/installation. "Safe by design". An opportunity available for new machines.

Principle 2: GUARDING

Enclose and guard against hazards that cannot be designed out. Install guarding.

Principle 3: DEFINE RESIDUAL RISKS

Manage residual risks. Enclose and guard against hazards that cannot be designed out or can be enclosed/guarded. Means include: information, awareness, procedures, training, access control, etc.

We are here to help you

Rest assured that Goodtech is here to support you. If you have any questions or require further information, please don't hesitate to contact us. We are here to assist you every step of the way.