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17 Jul 2026 7 min read

Declaration of Conformity: Machinery Reg 2023/1230 Guide

A practical guide to writing your EU Declaration of Conformity under Regulation 2023/1230. Covers Annex V requirements and conformity assessment.

Declaration of Conformity: EU Machinery Reg 2023/1230 Guide

In our previous article, we covered what Regulation (EU) 2023/1230 changes for manufacturers and why it matters. This article gets practical: how to write the Declaration of Conformity (DoC) that your machinery will need from 20 January 2027 onwards.

The DoC is one of the most visible compliance documents you produce. It travels with every machine you place on the EU market. Get it wrong, and market surveillance authorities will notice before your customers do.

Claims Checklist

Claim Source
Declaration of Conformity format defined in Annex V of Regulation 2023/1230 Annex V
Technical documentation requirement and retention Art. 10(2)
Manufacturer must provide Declaration of Conformity with required mandatory content Annex V
Technical file and supporting documentation preserved per regulatory requirements Annex IV
Application date of Regulation 2023/1230 is 20 January 2027 Art. 54

What changes in the Declaration of Conformity

Under Directive 2006/42/EC, the DoC followed a format defined in Annex II, Part 1, Section A. Under Regulation (EU) 2023/1230, the format moves to Annex V.

The structural logic is similar — a signed document stating that a specific product conforms to specific requirements. But several details change, and those details matter for compliance.

The most common mistake is treating the new DoC as a copy-paste exercise from your old template. It is not. Annex V defines specific mandatory content, and auditors will check against it.

Mandatory content under Annex V

Annex V of Regulation (EU) 2023/1230 defines the minimum content that every EU Declaration of Conformity must include. Here is what your DoC must contain:

1. Manufacturer identification Full business name and postal address of the manufacturer. If you use an authorised representative established in the EU, their name and address must also appear.

2. Machine identification The DoC must clearly identify the machinery or related product it covers. This means: product description, type, serial number (where applicable), and any other information that unambiguously identifies the specific product.

3. Statement of conformity An explicit statement that the EU Declaration of Conformity is issued under the sole responsibility of the manufacturer. This is not a formality — it assigns legal liability.

4. Applicable legislation The DoC must list all Union harmonisation legislation with which the product complies. For machinery falling under Regulation 2023/1230, you must reference Regulation (EU) 2023/1230 — not Directive 2006/42/EC. If other regulations also apply (e.g., EMC Directive, Low Voltage Directive), list those as well.

5. Harmonised standards used If you applied harmonised standards to demonstrate conformity, list them with their reference numbers and dates. If no harmonised standards were used (or only partially), state which other technical specifications were applied.

6. Notified Body details (where applicable) If a Notified Body was involved in the conformity assessment procedure, include: the name, the identification number, and a reference to the certificate issued.

7. Signature, date, and place The DoC must be signed by a person authorised to act on behalf of the manufacturer. Include the place and date of issue.

This is not a suggested format — it is the minimum mandatory content. Omitting any of these elements means your DoC does not conform to Annex V.

Self-assessment vs Notified Body: which path applies to you

Regulation 2023/1230 provides two conformity assessment routes. Which one you must follow depends on your product classification.

Route A: Self-assessment

For machinery that is not classified as high-risk under Annex I, the manufacturer can perform a self-assessment. You evaluate your product against the essential health and safety requirements, compile the technical documentation (Annex IV), and issue the Declaration of Conformity (Annex V) yourself.

This is the path most SME manufacturers will take. It does not mean the assessment is less rigorous — it means you bear full responsibility for the evaluation without third-party verification.

Route B: Notified Body involvement

For machinery classified as high-risk under Annex I, a Notified Body must be involved in the conformity assessment. You cannot self-declare conformity for these categories.

Annex I includes two categories that are new to this Regulation, both related to artificial intelligence:

  • Safety components with self-evolving behaviour enabled by machine learning approaches
  • Machinery with embedded AI systems that ensure safety functions

If your machinery or safety components fall under any Annex I category, contact a Notified Body early. Their capacity is limited, and lead times for assessment can be significant.

How to check: Review the complete list in Annex I, Part A of Regulation 2023/1230 and compare it against every product in your range. Do not assume your product is not listed — verify.

Digital format: what is and is not required

Regulation 2023/1230 permits the Declaration of Conformity, technical documentation, and instructions for use to be provided in digital format (Art. 10(7)).

This is a notable change from Directive 2006/42/EC, which did not explicitly address digital documentation.

Key points on digital format:

  • Digital is permitted, not mandatory. You may continue issuing paper DoCs. The choice is yours.
  • If you choose digital, ensure the document remains accessible and readable for the duration required by the Regulation.
  • Electronic signatures are valid under the Regulation's digital documentation provisions.

A note on ongoing legislative discussions: the proposed Omnibus IV package includes provisions that could make digital documentation mandatory in the future. As of July 2026, this proposal is still under debate and has not been adopted. Do not plan your compliance programme around provisions that may or may not become law. Plan around what is in force today.

Cybersecurity: a new essential requirement

Section 1.1.9 of Regulation 2023/1230 introduces cybersecurity as a core essential health and safety requirement. Your machinery must be protected against corruption and unauthorised modification of its software and data.

This is relevant to the DoC because you are declaring conformity with all applicable essential requirements — and cybersecurity is now one of them. If your machinery has software, network connectivity, or updateable firmware, your risk assessment and technical file must address Section 1.1.9.

Substantial modification: when a new DoC is required

Regulation 2023/1230 introduces the concept of substantial modification (Art. 18). When modifications to machinery that were not foreseen by the original manufacturer affect its conformity with the essential requirements, the person who carries out that modification is treated as the manufacturer.

In practice, this means: if you substantially modify a machine after it was placed on the market, you must issue a new DoC under your own responsibility — covering the modified machine against the Regulation's requirements.

This provision did not exist in Directive 2006/42/EC. If your business involves retrofitting, upgrading, or modifying machinery, pay close attention to Art. 18.

DoC writing checklist

Before you issue your next Declaration of Conformity under Regulation 2023/1230, verify:

  • The DoC references Regulation (EU) 2023/1230, not Directive 2006/42/EC
  • Manufacturer name and full postal address are present
  • Authorised representative details are included (if applicable)
  • The machinery is unambiguously identified (description, type, serial number)
  • All applicable Union harmonisation legislation is listed
  • Harmonised standards applied are listed with reference numbers and dates
  • Notified Body name, number, and certificate reference are included (if applicable)
  • The DoC is signed by an authorised person, with date and place of issue
  • Your technical file (Annex IV) addresses cybersecurity (Section 1.1.9) if applicable
  • You have confirmed whether your product requires Notified Body involvement (Annex I)
  • If providing the DoC digitally, you have a plan for long-term accessibility

What comes next

We are building a tool that generates your Regulation 2023/1230 Declaration of Conformity automatically. You input your product and manufacturer details, select applicable standards, and it produces a compliant Annex V document — ready for signature and export.

If you are preparing for the transition, this is the kind of operational step that should not consume your engineering team's time.

Join the early access waitlist

This article references Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023. For the full text, see EUR-Lex. This content is informational and does not constitute legal advice. Consult your Notified Body or regulatory advisor for guidance specific to your products.