Our training enables a do-it-yourself approach using publicly available AI, retaining know-how in-house and reducing recurring spend. Verification of AI outputs is carried out by the client's competent staff; we supply guidance on how to verify. We also provide verification service (one-off or subscription-based) upon the client's need. This model will help control the common risks of non-compliance or recall.
Industrial machinery — presses, CNC machines, conveyors, packaging machines, robotics.
Consumer machinery — lawnmowers, power tools, household machinery.
Construction and agricultural machinery — excavators, loaders, tractors (where not covered by specific regulations).
Lifting equipment — cranes, hoists, lifts (except those covered by the Lifts Regulation).
Partly completed machinery — assemblies requiring further integration before use.
Safety components — including software‑based safety functions.
AI‑enabled or software‑driven machinery — collaborative robots, autonomous vehicles, connected machinery, machinery with machine‑learning safety functions.
High‑risk machinery — six categories requiring mandatory third‑party conformity assessment.
Manufacturers (EU and non‑EU)
Importers
Distributors
Integrators / assemblers of production lines
Manufacturers of safety components and software
Risk assessment
Must explicitly address new and emerging risks, including cybersecurity, software behaviour, AI‑related hazards, and human–machine interaction.
Must follow updated Essential Health and Safety Requirements (EHSRs) in Annex III of the Regulation.
Must be included in the technical documentation and kept available for market surveillance authorities.
Higher‑risk categories may require more detailed analysis and third‑party involvement.
Technical documentation (Technical File)
Must include all design, manufacturing, and operational information, as before, but now expanded to cover:
software and algorithmic safety functions
cybersecurity measures
digital control systems
validation of AI‑based safety functions
Digital‑only documentation is permitted under certain conditions.
Must be retained for authorities for the required period.
EU Declaration of Conformity (DoC)
Must reference Regulation (EU) 2023/1230 instead of the Machinery Directive.
Must list all other applicable EU legislation (e.g., EMC, LVD, RED).
Must identify harmonised standards used to claim presumption of conformity.
Cannot be issued under the Regulation before 20 January 2027.
Harmonised standards and presumption of conformity
Applying harmonised standards cited in the Official Journal of the EU (OJEU) continues to provide voluntary presumption of conformity.
Manufacturers may use alternative solutions, but these require additional evidence to demonstrate compliance with Annex III.
Conformity assessment
Uses standard EU “modules” (e.g., internal control, type examination).
Internal control remains possible for most machinery.
High‑risk machinery (six categories) requires mandatory Notified Body involvement.
No transitional period: from 20 January 2027, only the Regulation applies.
Regulation (EU) 2023/1230 full text (EUR‑Lex):
http://data.europa.eu/eli/reg/2023/1230/oj
DGUV overview of conformity assessment and transition:
https://www.dguv.de (Machinery Regulation section)
SGS summary of key changes and high‑risk categories:
https://www.sgs.com (EU Machinery Regulation 2023/1230)
etc.