Presumption of Conformity Under the EU Machinery Regulation: What Manufacturers Need to Know

As the industry moves from the Machinery Directive (2006/42/EC) to the Machinery Regulation (EU) 2023/1230, one principle remains central to demonstrating compliance: presumption of conformity. While the Machinery Regulation introduces substantial updates (especially around digitalization, AI, and cybersecurity) the strategic value of using harmonized standards is stronger than ever.

The recent developments from CEN and CENELEC, along with the European Commission's 2025 Standardization Request, signal a crucial shift in how manufacturers should prepare for market access.

Why Harmonized Standards Still Matter

The Machinery Regulation clearly states that harmonized standards remain voluntary, but their importance is undeniable. Applying them gives manufacturers the strongest, most defensible path to proving compliance, ensuring that machinery meets the Regulation’s Essential Health and Safety Requirements (EHSRs).

Using harmonized standards provides:

• A predictable compliance pathway
• A stable technical basis for conformity assessment
• A reduced burden of proof in the event of audits or market surveillance actions

Under Recital 48 of the Regulation, manufacturers are not obligated to use harmonized standards—but doing so remains the most effective strategy for demonstrating conformity.

The 2025 Standardization Request: A Turning Point

On 20 January 2025, the European Commission issued Implementing Decision C(2025) 129, mandating CEN and CENELEC to:

• Update harmonized standards developed under the Machinery Directive
• Finalize ongoing standards development
• Create new harmonized standards supporting the Machinery Regulation

This includes detailed deadlines for deliverables, with the first major milestone (Phase 1 draft standards) submitted by January 20, 2026.

These Phase 1 deliverables specifically target areas where the EHSRs have significantly changed. Manufacturers should expect updates in areas such as:

• Digital documentation
• Software and AI-driven functions
• Cybersecurity requirements
• Safety-related control systems

What Happens Next?

Following the submission of new draft harmonized standards:

1. The European Commission reviews each standard under Article 10(5) of Regulation (EU) 1025/2012.
2. If confirmed to satisfy the Machinery Regulation, the Commission will publish the standard’s reference in the Official Journal of the European Union (OJEU).
3. Only upon publication does a harmonized standard officially grant presumption of conformity.

In parallel, the Machinery Regulation permits the Commission to develop Common Specifications (CS) where harmonized standards do not yet exist. However, no Common Specifications for the Machinery Regulation are currently known to be in development.

High‑Risk Machinery: A Significant Shift

Under the Regulation, machinery listed in Part B of Annex I is considered high‑risk. Unlike under the Directive, these products can no longer be self‑declared when harmonized standards are not fully applied.

This means:

• Notified Body involvement becomes mandatory
• Manufacturers must prepare for third‑party conformity assessment
• Technical documentation and risk assessments will face deeper scrutiny

This shift underscores why aligning with harmonized standards is the most efficient path forward

How Intertek Supports Your Transition

As the EU enters this new regulatory era, Intertek provides the expertise and capabilities manufacturers need to maintain market access and ensure full compliance.

We assist with:

• Harmonized standard gap analysis and transition planning
• Technical documentation and risk assessment reviews
• Conformity assessment for high‑risk machinery
• AI, software, and cybersecurity evaluations aligned with the new EHSRs
• Support in navigating Notified Body requirements under the Regulation

Intertek’s expanding role, including recent designations toward becoming a Notified Body under the new Machinery Regulation, ensures manufacturers have a trusted partner through every step of the transition.

Conclusion

The shift from the Machinery Directive to the Machinery Regulation represents one of the most substantial updates to EU machinery compliance in decades. While the regulatory framework evolves to address modern technologies, presumption of conformity through harmonized standards remains the anchor of compliance strategy.

With new standards underway and high‑risk machinery facing heightened oversight, manufacturers must act now to prepare their technical files, align with updated standards, and plan for future conformity assessments.

Intertek stands ready to help you navigate this transition, ensuring your machinery remains compliant, safe, and ready for the EU market of tomorrow.