Six steps to conformity with the Machinery Regulation

Decide which of your products fall under the Regulation and which conformity route applies to each

• List machinery, related products and partly completed machinery you place on the market or put into service (Art. 2(1))
• Check the exclusions of Art. 2(2), for example fairground equipment, weapons and means of transport
• Check Annex I: Part A needs a notified body, Part B allows internal control only with full standards coverage (Art. 6, Art. 25)
• Decide whether a change to an existing product is a substantial modification that makes you the manufacturer (Art. 3(16), Art. 18)

Art. 2 (scope), Art. 3 (definitions), Art. 6 and Annex I (categories), Art. 18 (substantial modification)

Note. Software that fulfils a safety function and is sold separately is a safety component in its own right (Art. 3(3)).

Run the risk assessment the Regulation requires and design out the hazards, including the digital ones

• Carry out and document the risk assessment following the general principles of Annex III
• Apply the essential health and safety requirements that follow from that assessment (Art. 10(1), Annex III)
• Design connections and remote access so they cannot lead to a hazardous situation; protect and identify safety-critical software and data; collect evidence of interventions (Annex III, 1.1.9)
• Design control systems that withstand reasonably foreseeable malicious attempts and whose faults or logic errors do not lead to hazardous situations (Annex III, 1.2.1)

Art. 8 and 10(1), Annex III (general principles, 1.1.9 protection against corruption, 1.2.1 safety and reliability of control systems)

Note. Where machinery is also a product with digital elements, the Cyber Resilience Act applies as well; its recital 53 notes that meeting its cybersecurity requirements can facilitate meeting the Machinery Regulation requirements that cover similar risks.

Annex IV lists what the file must contain before you place the product on the market

• Describe the product and its intended use (Annex IV, Part A(a))
• Include the risk assessment documentation with the list of applicable essential requirements (Annex IV, Part A(b))
• Keep the documentation and the EU declaration of conformity available for at least 10 years (Art. 10(3))
• Be ready to provide source code or programming logic on a reasoned request when it is needed to check compliance (Art. 10(3))

Art. 10(2) and (3), Art. 11(2), Annex IV

Note. Build the file while designing. A file assembled afterwards rarely shows the reasoning the risk assessment requires.

Internal production control, or one of the notified-body modules, depending on Annex I

• Outside Annex I: internal production control, module A (Art. 25(4), Annex VI)
• Annex I, Part B: module A only when designed fully to harmonised standards or common specifications; otherwise module B with C, module H or module G (Art. 25(3))
• Annex I, Part A: EU type-examination (module B, Annex VII) with conformity to type (module C, Annex VIII), full quality assurance (module H, Annex IX) or unit verification (module G, Annex X) (Art. 25(2))
• Choose a notified body where required (Art. 26 to 42)

Art. 25, Art. 26 to 42 (notified bodies), Annexes VI to X

Note. Notified bodies must take the interests and needs of small and medium-sized enterprises into account when setting fees (Art. 25(5)).

EU declaration of conformity, CE marking, identification, contact details and instructions

• Draw up the EU declaration of conformity per Annex V, Part A, keep it updated and translated as required (Art. 21)
• Affix the CE marking visibly, legibly and indelibly before placing on the market or putting into service (Art. 24)
• Mark model, series or type, year of construction and serial or batch identification, and your name and contact details (Art. 10(5) and (6))
• Supply the instructions and Annex III information, digital where allowed, with the safety information for non-professional users on paper (Art. 10(7))

Art. 10(5) to (8), Art. 21, Art. 23 and 24, Annex III section 1.7.4, Annex V

Note. The declaration must be continuously updated (Art. 21(2)): a software change that affects safety usually means a new version of the declaration.

Series production, complaints, corrective action and cooperation with market surveillance

• Keep procedures so series production stays in conformity, including after changes in design, production or standards (Art. 10(4))
• Sample-test and investigate where the risks warrant it; keep a register of complaints, non-conforming products and recalls (Art. 10(4))
• Take corrective action, withdraw or recall when a product is not in conformity, and inform the national authorities where it presents a risk (Art. 10(9))
• Provide information and documentation on a reasoned request and cooperate on risk-eliminating actions (Art. 10(10))

Art. 10(4), (9) and (10), Art. 43 to 46, Art. 52

Note. A substantial modification after placing on the market, including by digital means, restarts the obligations for the person who makes it (Art. 18).