Machinery Directive – CE Marking and New Machinery Regulation
The Machinery Directive 2006/42/EC governs the market placement and free movement of machines within the European Economic Area (EEA). As of December 29, 2009, compliance with this directive became mandatory.
However, a significant change is forthcoming. On June 29, 2023, the Machinery Regulation (Regulation (EU) 2023/1230) was published. This new regulation replaces Machinery Directive 2006/42/EC. The Machinery Regulation will take effect 42 months after its publication, precisely on January 20, 2027. Notably, some rules applicable to Member States have exceptions, such as the notification of conformity assessment bodies and the definitions of penalties within the EU. It’s worth highlighting that there are no transitional provisions bridging the gap between the Machinery Directive and the Machinery Regulation. Therefore, manufacturers must continue to adhere to the Machinery Directive until January 19, 2027, after which compliance with the new Machinery Regulation becomes mandatory.
Conformity Assessment can be undertaken by the manufacturer, but certain conditions require assessment by a notified body. These conditions include:
- The product is listed in Appendix IV of the Machinery Directive (or Annex I of the new Machinery Regulation)
- There is no harmonized standard listed for the product
- The harmonized standard does not cover all relevant safety and health requirements
Following the conformity assessment, a Declaration of Conformity is required. If a product falls under the jurisdiction of the EC Directive, a CE marking is also necessary and is the responsibility of the producer to affix to the product.
How We can Help You
At innotec, we are dedicated to supporting you in navigating the complex landscape of machinery regulation. Our team is here to guide you through the necessary steps and formalities to ensure your compliance. Our services include:
- Researching all relevant directives, standards, and legal provisions
- Conducting risk assessment
- Compiling all necessary documentation
- Drafting conformity assessments
- Preparing the Declarations of Conformity
- Facilitating interactions with external notified bodies, when required
Ready to integrate Functional Safety into your project?
Contact us now, and together, we will discover the perfect service for your needs.