Applicable law and conformity route
Machinery Regulation 2023/1230 entered into force on 19 July 2023 and its main requirements apply from 20 January 2027, following the corrigendum. Before that date, assess machinery under Directive 2006/42/EC as applicable. Annex I Part A of the Regulation requires a specified third-party route; Part B can allow internal control under Article 25’s conditions. Neither every Annex I machine nor every safety component automatically requires Module B.
Standards and their limits
Harmonised standards are generally voluntary. A current OJ citation can provide a presumption of conformity for covered requirements. For Annex I Part B, internal control is conditional on the full coverage required by Article 25; otherwise use a permitted third-party route. The old Directive’s Annex IV also does not universally require type examination.
Practical checklist
- Identify the product, intended use, market and applicable legal scope.
- Record the exact legal provisions, dates and applicable standard editions, including restrictions.
- Select the permitted assessment route and document the evidence needed.
- Link risk assessment, tests, product versions and declarations in the technical documentation.
- Assign responsibility for changes, support and responses to authorities.
This checklist supports planning; the applicable legal requirements determine the final assessment.