About this template
EU Machinery Regulation 2027 – complete compliance package
This is a practical and editable template package for companies that manufacture, import, distribute, or modify machinery and related products in preparation for the transition to Regulation (EU) 2023/1230. The regulation will generally apply from January 20, 2027, and replaces the Machinery Directive 2006/42/EC.
The package is designed to help companies structure their work regarding scope, Annex I, conformity route, risk assessment, technical documentation, EU declaration, CE, digital instructions, cyber/software security, and substantial modification. The documents are in Swedish + English and are delivered in Word, PDF, and Excel.
Includes
- Compliance plan for the transition to the Machinery Regulation 2027
- Scope, Annex I & Conformity Route assessment
- Risk assessment according to Annex III
- Technical File according to Annex IV
- EU Declaration of Conformity & CE check
- Substantial Modification Assessment according to Article 18
- Digital Instructions, Cyber & AI check
- Separate user guide
- All of the above documents in Swedish and English
- Excel-based Machinery Regulation Compliance Register with dashboard and work register
The Excel register contains
Dashboard, Product Register, Annex I & Route, EHSR Matrix, Risk Register, Standards, Technical File, EU DoC & CE, Digital Instructions, Cyber & AI, Change Control, Release Gate, and Sources.
Key 2027 changes
The package distinguishes between products placed on the market under the Machinery Directive 2006/42/EC before January 20, 2027, and products covered by the new regulation after the transition. It also includes checks for physical and digital substantial modifications, where the party making the change may assume manufacturer liability for the product in question.
Furthermore, the regulation contains clearer requirements for digital instructions and the protection of safety-critical hardware, software, and data. Annex I also covers certain safety components and embedded systems with fully or partially self-learning machine-learning behavior that ensures safety functions.
For whom?
- Machine manufacturers and OEMs
- Importers and distributors
- System integrators and automation companies
- Machine builders and engineering departments
- CE/compliance officers
- Quality, technical, and safety functions
- Companies that rebuild or digitally modify existing machines
Format and language
16 Word files + 16 PDF files + 1 Excel file. A total of 33 delivery files in a ZIP package. Language: Swedish + English.
Legal basis
Regulation (EU) 2023/1230 on machinery, including the current consolidated version as of October 6, 2026. The package takes into account, among others, Articles 10, 18, 25, 51, 52, and 54 as well as Annexes I, III, and IV.
Important
The templates are a structured compliance foundation and do not replace product-specific engineering assessments, testing, harmonized standards, or a notified body when required. Always check other applicable EU product legislation for the specific machine.
Legally and technically reviewed: October 6, 2026.
