From Directive to Regulation: Navigating Presumption of Conformity in the EU’s New Machinery Framework

09 Feb 2026

Why Harmonized Standards Matter

Presumption of conformity through the use of harmonized standards remains one of the most important concepts for anyone working with the Machinery Regulation. Although the Regulation makes it clear that the use of harmonized standards is voluntary (see Recital 48 of Regulation (EU) 2023/1230), applying them provides manufacturers with the clearest, most stable, and most defensible basis for demonstrating that a product meets all relevant requirements.

The 2025 Standardization Request

On 20 January 2025, the European Commission issued Implementing Decision C(2025) 129. This decision formally requested CEN and CENELEC to amend or revise existing harmonized standards developed under the Machinery Directive (2006/42/EC), finalize works already underway, and draft new harmonized standards to support the Machinery Regulation (EU) 2023/1230. This mandate is explicitly stated in point 17 of the Decision.

The Annexes to the Decision set out the deadlines that CEN and CENELEC must meet. The first major milestone was 20 January 2026, marking the deadline for the adoption of Phase 1 deliverables.

Annex I, Table 1 of the Decision describes the Phase 1 deliverables as priority deliverables where new harmonized standards are needed to reflect the updated Essential Health and Safety Requirements (EHSRs) of the Machinery Regulation, particularly where requirements have changed compared to the Machinery Directive.

In practical terms, by 20 January 2026, CEN and CENELEC were required to submit their initial package of draft harmonized standards to the European Commission.

What Happens Next?

With the initial work now submitted, the process moves to the European Commission. Under Article 10(5) of Regulation (EU) 1025/2012, the Commission will review the standards in cooperation with the European standardization bodies.

Only when a standard is confirmed to meet the requirements of the Machinery Regulation will the Commission publish its reference in the Official Journal of the European Union.

In parallel, the Machinery Regulation also allows the Commission to publish Common Specifications where no harmonized standards exist. These Common Specifications can also confer presumption of conformity. At this time, however, no Common Specifications are known to be in development for Machinery Regulation purposes.

Why This Matters

A significant change introduced by the Machinery Regulation concerns high‑risk machinery listed in Part B of Annex I. Under the new framework, these products may use Module A (internal production control) – without a notified body – but only if harmonized standards or Common Specifications exist that cover all applicable EHSRs (see this blog post for more information).

This makes the timely availability of harmonized standards critically important for manufacturers wishing to rely on Module A for high‑risk machinery.

How You Can Prepare

Our team continues to participate actively in key technical committees and to monitor all EU developments related to the Machinery Regulation and standardization.

As soon as the first list of harmonized standards is published in the Official Journal, we will notify our clients through our established communication channels. Staying informed will be essential for manufacturers planning their compliance strategies well ahead of 20 January 2027, when the Machinery Regulation begins to apply.