Skip to content

CE conformity for machinery: not an "inspection", but self-certification

Machine safety

Many organisations ask for a "CE inspection", but for machinery it works differently: the manufacturer declares conformity itself and affixes the CE marking. In this article we clearly explain when self-certification is sufficient and when a notified body is required (Annex I, Part A/B).


CE conformity for machinery: not an

For machinery, it is not a matter of a classic inspection by an external body. It is the manufacturer who demonstrates that the machine meets the Essential Health and Safety Requirements (EHSR), draws up a technical construction file, signs the (EU) declaration of conformity and affixes the CE marking. This was already the case under Machinery Directive 2006/42/EC and remains so under the EU Machinery Regulation 2023/1230. For most machinery, self-certification is therefore sufficient.

Exception: “high-risk” categories:
For certain categories of machinery, a notified body is (sometimes or always) involved. The Machinery Regulation groups these in Annex I, split into Part A and Part B:

  • Annex I – Part A: categories for which third-party assessment is always mandatory. This is a newer, stricter subset than under the Machinery Directive.
  • Annex I – Part B: categories for which third-party assessment is only mandatory if the relevant risks are not fully covered by harmonised standards. If they are fully covered, self-certification may be sufficient. Functionally, this is the equivalent of the “Annex IV machinery” under the Machinery Directive, which could also follow internal production control when the standards were fully applied.

Case: CE process for a (catheter) packaging line