Exporting machinery to the EU:
stay compliant from day one.

Machinery may only be placed on the EU market or put into service if it meets the essential health and safety requirements of Annex I and carries the CE marking. CE marking is a manufacturer's self-declaration backed by documentation, not an approval issued by an EU authority. A notified body is mandatory only for the Annex IV categories that are not built fully to harmonised standards covering all relevant requirements.

The Machinery Regulation replaces the Directive on one fixed day. Every unit placed on the EU market from 20 January 2027 must comply with the Regulation; there is no transition for newly built machines. What counts is the first supply of each individual unit on the Union market. For the six categories in Annex I Part A a notified body is always mandatory from that date.

Annex I obliges the manufacturer to carry out a risk assessment to determine which requirements apply, and to design the machine taking its results into account. EN ISO 12100 is the harmonised method standard: limits of the machine, hazard identification across all life phases, risk estimation and evaluation, then risk reduction in the mandatory three-step order (inherently safe design, safeguarding, user information).

Standards cited in the Official Journal of the EU give a presumption of conformity for the requirements they cover. They are voluntary, the essential requirements are not. Applying the current cited edition, and a type C standard where one exists for your machine family, is the practical route to a defensible design. As of August 2026 no standard has yet been cited under the new Regulation; a first citation decision is expected towards the end of 2026.

General description, drawings and control circuits, calculations and test results, the risk assessment documentation, the standards applied, test reports, the instructions and the declarations. It must be available for 10 years (under the Directive from the date of manufacture, for series production of the last unit; under the Regulation from placing on the market) and be capable of being assembled on a reasoned request within a period commensurate with its complexity.

The declaration identifies the machine, the manufacturer, the applicable EU acts and the standards applied, and is signed by the manufacturer. Until 19 January 2027 it must also name a person established in the Community who is authorised to compile the technical file. From 20 January 2027 it names only the manufacturer and, where appointed, the authorised representative, and it may be provided digitally.

Instructions must accompany the machine in the official EU language or languages of the member state where it is placed on the market or put into service, marked as original instructions or as a translation of the original instructions. English alone is sufficient only where English is an official language. From 2027 the Regulation allows digital instructions under defined conditions, with paper on request at the time of purchase.

Since 16 July 2021 machinery may only be placed on the EU market if an economic operator established in the Union is responsible for defined compliance tasks: an EU manufacturer, an importer, an authorised representative with a written mandate or, where none of those exists, an EU fulfilment service provider. Its name and contact details including a postal address must appear on the product, its packaging, the parcel or an accompanying document.

Authorities can request the declaration and the technical file on a reasoned request, and the authorities controlling imports must suspend the release of a product when required documentation or markings are missing or no Article 4 operator can be identified. Failure to present the technical file may in itself be grounds for doubting conformity. Keep the declaration and the file for 10 years.