The Origin of Machine Instructions
"In the 1990s, there was a village called Ou Village. The big households in the village all had their own machinery industries and rules. If Lao Wang wanted to sell his machinery to Lao Li, the products had to meet Lao Li's requirements; if he wanted to sell another batch to Lao Zhang, he had to meet Lao Zhang's rules. The reverse was also true. If Lao Wang wanted to buy Lao Li's machines, then those machines had to meet Lao Wang's standards. As a result, a lot of time and money were wasted in the coordination process."
Later, the village committee discussed it and decided to formulate a rule applicable to the entire village. All products subject to this rule must be labeled to prove that they meet the rule, so that they can be freely sold to everyone in the village.
If someone wants to purchase products from outside the village for use within the village, they must also comply with the rules of the European village. This is the origin of the Machine Instruction.
"Passport to Europe"
The rule mentioned in the story is the famous EU Machinery Directive.
The new EU Machinery Directive 2006/42/EC came into effect on December 29, 2009, with the aim of eliminating trade barriers within Europe and creating a free market in Europe.
It does not focus on technical details, but rather on safety and health regulations related to mechanical design and structure.
CE is an abbreviation for the European Community. Manufacturers affix the CE mark to certify that the product complies with the Machinery Directive and all relevant European internal directives, and has completed the applicable EC Declaration of Conformity process.
Products bearing the CE mark can be freely imported and sold within the European Union and are known as "passports to Europe".
Scope of constraints of machine orders
From January 1, 1995, all machinery used for the first time within the EU, regardless of its country of origin or production date, must comply with the EU Machinery Directive, the scope of which is as follows:
All new products, whether manufactured in EU member states or outside the EU;
Used and secondhand products imported from countries outside the EU;
Upgraded machines, where products have been modified to a certain extent, may pose new dangers. If analysis determines that the modifications constitute significant changes, the same certification process as for new machines will be applied.
Even if each individual component of an assembly machine has a CE mark, the machine assembled from these components must still undergo the CE certification process.
If an incident in one interconnected machine affects the security of another, the entire interconnected machine system must be CE certified.
Semi-finished machines refer to machines that cannot perform a specific function on their own and can only be intended for installation in other machines or assembly with other semi-finished machines.
Interchangeable equipment is marketed for use in machines to adjust their functions, not as spare parts or tools.
Who is responsible for CE certification?
According to the Machinery Directive, a machine manufacturer refers to any natural or legal person who designs and/or manufactures machinery or semi-finished machinery, or is responsible for putting products on the market or delivering them for use.
The manufacturer could be the actual manufacturer, assembler, distributor, or even the operator who modified the machine.
The manufacturer or its authorized representative will be responsible for carrying out the CE certification process.
Regarding Authorized Representatives
Only authorized representatives established within the EU can sign the EC Declaration of Conformity. Once the EC Declaration of Conformity is signed, the legal responsibilities of the natural or legal person become effective.
Pilz is one of the few authorized professional representative offices in Europe.
Proficient in existing standards and possesses extremely high technical qualifications
With extensive experience and a standardized CE certification process, we save our clients time.
A trustworthy inspection agency for machinery and safety equipment with DAkkS certification.
Ensure that customers' products can enter the European market
Right to sign EC Declaration of Conformity
Pilz's responsibilities related to CE certification:
Identify and comply with relevant standards and directives.
Assess risks
Establish a safety concept and implement safety design.
Assess compliance with basic health and safety requirements and provide reasonable recommendations.
Conduct inspections, tests, and verifications.
Documents required for the development and archiving of regulations, including technical structure documents.
Responsible for signing the EC Declaration of Conformity
Affixing the CE mark and managing certificates
Pilz is a reliable partner for its customers' CE marking and machinery safety related services.
Pilz is one of the few companies that can be responsible for carrying out the compliance assessment process and will sign the compliance declaration as the customer's authorized representative, confirming that the machine complies with the requirements of the Machinery Directive 2006/42/EC.
