CE Marking Machine Ref. M-2847. Technical File and Declaration of Conformity.

The primary directive is the Machinery Directive 2006/42/EC, which will apply until 14 January 2027 when it will be replaced by Regulation (EU) 2023/1230. Depending on the type of machinery, other directives may apply simultaneously: the Low Voltage Directive 2014/35/EU (if the machine has electrical components), the EMC Directive 2014/30/EU (for electromagnetic compatibility), the ATEX Directive 2014/34/EU (if operating in explosive atmospheres), the Ecodesign Directive (for certain equipment), and from 2027, the Artificial Intelligence Regulation if the machine incorporates high-risk AI systems. IgeraIndustria lets you query which directives apply for each machine type in seconds.

Annex VII of the Machinery Directive 2006/42/EC defines the minimum content of the technical file (Part A): general description of the machine; assembly drawings and, where applicable, control circuit drawings; detailed drawings with calculations, test results and certificates; list of essential health and safety requirements applied; list of harmonised EN standards applied; results of risk assessments; copy of the instructions for use; where applicable, copies of declarations of conformity of incorporated components; signed copy of the EU Declaration of Conformity. For Annex IV machines using CE type examination, Part B with additional documentation for the notified body must be added. IgeraIndustria makes each section of Annex VII queryable so you know exactly what goes in each part.

The EU Declaration of Conformity (DoC) under Machinery Directive 2006/42/EC (Annex II.A) must mandatorily include: full name and address of the manufacturer or authorised representative; description of the machinery (name, model, serial number where applicable); references to all applicable directives and harmonised standards; if a notified body was involved, its name, address and identification number; name, signature, and position of the person authorised to sign on behalf of the manufacturer. The DoC must be drawn up in the official language or languages of the country where the machinery is placed on the market. It is a legally binding document: the manufacturer declares under their sole responsibility that the machinery complies with all EU requirements.

A notified body (NB) is mandatory when the machinery is listed in Annex IV of the Machinery Directive 2006/42/EC and the manufacturer has not applied harmonised standards covering all essential requirements. The main Annex IV categories are: circular saws for wood; cold-metal pressing portable hand-held and/or hand-guided machinery; presses for the cold working of metals; injection or compression plastics and rubber moulding machinery; certain lifting equipment (jacks, shackles, load chains); underground equipment; and certain machinery for the manufacture of pyrotechnic articles. If the machine is in Annex IV but the manufacturer has applied EN harmonised standards published in the OJEU covering all essential requirements, they may opt for CE self-certification (Module A) without an NB, though they must notify the member state. IgeraIndustria responds with the exact Annex IV reference for any machine type.

According to Annex I.1.7.3 of the Machinery Directive 2006/42/EC, the CE marking must be affixed in a visible, legible, and indelible manner on the machine or on its data plate. The machine must carry an identification plate with: name and address of the manufacturer, designation of the series or type, serial number if applicable, year of manufacture, and the CE marking. The minimum height of the CE symbol is 5 mm; if enlarged or reduced, the proportions of the design must be maintained. It is prohibited to affix markings that could be confused with the CE marking. Regulation 2023/1230 maintains these requirements and adds the possibility of a digital plate for certain categories of machinery, pending regulatory development.

It depends on the extent of the modification. If the modification affects the risks of the machine (change of functions, extension of the field of application, modification of the safety system, change of critical safety components), the modified machine is considered practically a new machine and it is necessary to review the risk assessment, update the technical file, issue a new DoC, and affix new CE marking. If the modification is minor (replacement of consumable components, aesthetic modification without affecting risks), the manufacturer can maintain the existing CE marking by documenting the modification in the technical file. The European Commission guide on substantial modification provides practical criteria. IgeraIndustria has this guide and the Machinery Directive indexed to answer specific modification cases.