Machinery Directive and new EU Machinery Regulation: Enginext supporting businesses
We’re your operational partner to manage the entire pathway
From 20 January 2027, the Machinery Directive (2006/42/EC) – the regulation through which the European Union defines the safety requirements for the design, manufacture and placing on the market of machinery – will be replaced by the new EU Machinery Regulation 2023/1230. The objective, however, remains the same: securing the CE marking (link to CE marking page). Enginext supports companies through this transition and in producing all the technical documentation required.
What the new EU Machinery Regulation sets out
The new EU Machinery Regulation will apply directly across all Member States and introduces rules covering new technologies, such as artificial intelligence and cybersecurity. It also clarifies the responsibility of economic operators. The aim is to require manufacturers to embed safety from the earliest design stages. The new EU Machinery Regulation requires compliance with the EHSRs (Essential Health and Safety Requirements), the preparation of the information file, the instruction manual and the EC Declaration of Conformity with CE marking. Only for high-risk machinery is the involvement of a Notified Body mandatory.
How Enginext can help you
Enginext steps in as your single consultant and operational partner to manage the entire documentary and technical pathway required for conformity checks. We provide practical guidance on which reference to apply during the transition period leading up to the 20 January 2027 deadline.
Risk analysis and technical file
We support the drafting of technical documentation for products, equipment and complex systems. We identify potential hazards and define mitigation measures, making sure the technical file is structured in line with the essential safety requirements.
Managing new projects, modifications and extensions
We handle the technical and documentary verification activities for both new products and updates to existing machinery. We analyse the technical impact of variants and support any updates to the CE marking, assessing whether specific documentary extensions are needed.
Coordination with Notified Bodies
For machinery categories that require mandatory third-party checks, Enginext plans and coordinates the involvement of the Notified Body. We manage the technical liaison and integrate verification reports into the client’s technical file.
Everything with a single
point of contact
Enginext is your single point of contact for testing: our method centralises the management of laboratory trials, delivering the client a coherent technical output ready for documentary integration.
Who we work with
Our advisory service for machinery CE marking under the new Regulation is aimed at every player in the production chain operating in, or planning to enter, the European Union market.
Manufacturers and builders
of industrial machinery, complex systems and equipment needing a documentary framework for self-certification.
Makers of high-risk products
that are required to have the involvement and verification of a Notified Body.
Converters and body-builders
modifying or adding to existing machinery where changes need certifying.
Start-ups and international companies (non-EU)
including Asian manufacturers, who must comply with stringent European standards to sell their products in the EU.
Notified Bodies
looking to delegate the advisory work to an external technical partner to streamline the workflow.
Why choose Enginext
Methodological rigour and the ability to manage the entire pathway come together with:
Frequently
asked questions
I already have CE marking under Directive 2006/42/EC: will I have to redo the certification in January 2027?
No, a product already certified under the old Directive doesn’t automatically need to be re-certified. The pathway can, however, reopen if, after that date, a change is made (even to a single component) that conflicts with the requirements of the new Regulation: in that case, the extension or update will have to follow the new rules.
Does the new Machinery Regulation also apply to non-EU companies wanting to sell in Europe?
Yes, the new rules also apply to international manufacturers planning to place machinery and products on the European Union market.
What happens if the machine is old and lacks the original documentation?
For older machines or where the manufacturer can no longer be traced, the Machinery Directive pathway can become unworkable. In these situations, Enginext assesses compliance under Legislative Decree 81/2008 (Annex VIII). This route, less complex than full CE marking, allows the client to safeguard workplace safety and retain regular access to sites, grants and funding.
Is Enginext a Notified Body?
No, Enginext acts as a third-party consultant. Our role is that of a technical partner: we support the client in drafting the technical file and the risk analysis, coordinating any involvement of external notified bodies we work with for specific tests.