The introduction of the EU Machinery Regulation marks a significant step towards greater safety, sustainability and efficiency in the machinery industry. The regulation, which replaces the Machinery Directive 2006/42/EC, will become binding on January 14, 2027 and entails significant innovations that go beyond the previous requirements of the Machinery Directive. It regulates the safety requirements for machinery products in detail and strengthens the protection of employees and users in particular.
One of the main changes concerns the inclusion of modern technologies such as artificial intelligence and networked machines. These must now meet strict safety requirements in order to minimize potential risks. The regulation also extends the scope of application, which means that more products than before will be subject to the regulations. Manufacturers must therefore adapt their processes in order to meet the increased requirements and remain legally compliant.
Central obligations to act of the parties concerned:
- Commissioning of machinery only if the new health and safety requirements set out in Annex III are met
- In case of substantial modification of the machinery: fulfillment of the obligations of a manufacturer
Substantial modification: This means a physical or digital change to machinery or an associated product, not foreseen or planned by the manufacturer, after it has been placed on the market or put into service, which affects the safety of the machinery or associated product concerned by creating a new hazard or increasing an existing risk, making it necessary to add guards or protective devices to the machinery or associated product, the incorporation of which requires adaptation of the existing safety control system, or to take additional protective measures to ensure the stability or strength of the machinery or associated product concerned.
- Production of machinery in compliance with the new health and safety requirements set out in Annex III
- Implementation of conformity procedures and preparation of technical documentation
- Issuing the EU Declaration of Conformity and affixing the CE marking
- For partly completed machinery: Issue of the EU Declaration of Incorporation and assembly instructions
- Attach the operating instructions and health and safety information
- Attach the EU Declaration of Conformity or EU Declaration of Incorporation or a reference to their digital form
- Retention of the technical documentation and declarations of conformity for ten years
- Verification of conformity for series production using suitable procedures
- Random testing of machines made available on the market
- Keeping a register of complaints, non-conforming machinery and recalls
- Designation of the model, series or type, year of manufacture and batch or serial number on the machine
- Designation of the name, registered trade names or trademarks, postal address, website and e-mail address or other digital contact option on the machine
- Taking corrective action if the machinery or associated products may not comply with the Machinery Directive
- Checking the required labeling and documentation on the machinery
- Notifying the manufacturer or importer if risks to health and safety or the environment become known
- Ensuring proper storage and transportation conditions
- Taking corrective action if the machinery or associated products may not comply with the Machinery Directive
- Placing on the market of only compliant machinery
- Notification to the manufacturer and the market surveillance authorities in the event of risks to health and safety or the environment becoming known
- Designation of the name, trade name, postal address, website and e-mail address or other digital contact option on the machine
- Ensuring proper storage and transportation conditions
- Retention of declarations of conformity or declarations of incorporation for ten years
- Keeping a register of complaints, non-compliant machines and recalls
- Taking corrective action if the machines or associated products may not comply with the Machinery Directive
This means that companies need to closely examine and adapt their existing machines and manufacturing processes. Understanding the new requirements and implementing them promptly are crucial in order to avoid sanctions and ensure marketability.
With this regulation, the EU is taking a further step towards greater safety and sustainability in the machinery sector. Companies that implement the new requirements at an early stage can not only minimize legal risks, but also secure competitive advantages.
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