Key Terms
- Machinery
- An assembly fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components at least one of which moves, joined together for a specific application [Art. 2(a)].
- CE marking
- The conformity marking consisting of the initials 'CE' per Annex III, indicating that the machinery meets all applicable essential health and safety requirements and has undergone the appropriate conformity assessment procedure [Art. 16].
- Harmonised standard
- A non-binding technical specification adopted by CEN, CENELEC or ETSI on the basis of a Commission remit. Machinery manufactured in conformity with a harmonised standard whose reference has been published in the Official Journal is presumed to comply with the essential requirements covered by that standard [Art. 2(l), Art. 7(2)].
- EC declaration of conformity
- A document drawn up by the manufacturer or authorised representative confirming that the machinery satisfies the relevant provisions of the Directive, listing applied Directives and harmonised standards. It must accompany every machine placed on the market [Art. 5(1)(e), Annex II Part 1 Section A].
- Notified body
- A conformity assessment body appointed by a Member State and notified to the Commission, authorised to carry out EC type-examination (Annex IX) or full quality assurance assessment (Annex X) for machinery listed in Annex IV [Art. 14].
- Partly completed machinery
- An assembly that is almost machinery but cannot in itself perform a specific application, intended to be incorporated into or assembled with other machinery to form a complete product. It is accompanied by a declaration of incorporation and assembly instructions, not by CE marking [Art. 2(g), Art. 13].
- Safety component
- A component which serves a safety function, is independently placed on the market, and whose failure or malfunction endangers persons — but which is not necessary for the machinery to function or for which normal components may be substituted [Art. 2(c)].
- Technical file
- The documentation compiled by the manufacturer per Annex VII Part A, including overall drawings, risk assessment results, descriptions of protective measures, harmonised standards used, test reports and a copy of the EC declaration of conformity. Must be available to authorities on request for at least 10 years [Annex VII].
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Frequently Asked Questions
What is the difference between the conformity assessment routes under Article 12?
For machinery not listed in Annex IV, the manufacturer may self-certify by carrying out internal checks per Annex VIII [Art. 12(2)]. For Annex IV machinery manufactured in full conformity with harmonised standards, the manufacturer may choose between self-certification (Annex VIII), EC type-examination (Annex IX) plus internal checks, or full quality assurance (Annex X) [Art. 12(3)]. If Annex IV machinery is not fully covered by harmonised standards, only EC type-examination or full quality assurance is permitted — self-certification is excluded [Art. 12(4)].
What counts as 'partly completed machinery' and what obligations does it carry?
Partly completed machinery is an assembly that is almost machinery but cannot itself perform a specific application — for example, a drive system intended for incorporation into other machinery [Art. 2(g)]. Before placing it on the market, the manufacturer must prepare technical documentation per Annex VII Part B, assembly instructions per Annex VI, and a declaration of incorporation per Annex II Section B [Art. 13(1)]. Partly completed machinery does not carry CE marking.
When does a manufacturer need to involve a notified body?
A notified body is required when the machinery falls into one of the 23 categories listed in Annex IV and is either not manufactured in full conformity with harmonised standards or the harmonised standards do not cover all relevant essential requirements [Art. 12(4)]. Even for Annex IV machinery made in conformity with harmonised standards, the manufacturer may voluntarily choose EC type-examination or full quality assurance [Art. 12(3)].
How does the safeguard clause work if a Member State considers CE-marked machinery unsafe?
Under Article 11(1), a Member State that ascertains CE-marked machinery is liable to compromise health and safety may withdraw it from the market, prohibit further placing on the market or restrict its free movement. The Member State must immediately inform the Commission and other Member States, stating whether the issue is a failure to meet essential requirements, incorrect application of harmonised standards, or shortcomings in the standards themselves [Art. 11(2)]. The Commission then decides whether the measure is justified [Art. 11(3)].
Will existing CE marking under Directive 2006/42/EC remain valid after 20 January 2027?
Machinery already placed on the market in conformity with Directive 2006/42/EC before 20 January 2027 may continue to be made available on the market. However, any machinery first placed on the market from 20 January 2027 must comply with the replacement Regulation (EU) 2023/1230 — the old Directive's declarations and certificates will not be sufficient for new placements after that date.
What information must the manufacturer's marking on the machinery include?
Each machine must bear, at minimum, the CE marking (per Annex III), the business name and full address of the manufacturer (or authorised representative), designation of the machinery, serial number and year of construction [Annex I, Section 1.7.3]. The CE marking must be affixed visibly, legibly and indelibly on the machinery itself [Art. 16(2)].
Does this Directive apply to machinery imported from outside the EU?
Yes. Any person who places machinery on the EU market or puts it into service is treated as the manufacturer if no EU-established manufacturer exists [Art. 2(i)]. This means importers of machinery from third countries assume all manufacturer obligations, including risk assessment, technical file, conformity assessment, EC declaration of conformity and CE marking [Art. 5(1)].
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