The all-in-one software solution for CE marking

CE marking is fundamentally a self-declaration by the manufacturer or the party placing the product on the market. With it, the manufacturer declares that the applicable health and safety requirements have been taken into account and that the product complies with the relevant European regulations.

An external expert is therefore not strictly necessary. What matters is that the CE process is carried out in a structured, technically sound and complete way – from reviewing the applicable legislation, through the risk assessment, to the technical documentation and declaration of conformity.

CERTAIN helps manufacturers carry out this process independently, digitally and step by step. For some machines, involving a notified body may be required.

Yes. You can test CERTAIN free of charge and with the full range of features for 30 days. There are no hidden costs and no automatic paid renewal.

Yes. You have full access to all features, including standards research, risk assessment, operating instructions and document generation.

When the trial period ends, you decide whether you would like to purchase a paid licence. There is no automatic renewal.

No. You don’t need a credit card for the trial version – just register and get started right away.

No. CERTAIN is so intuitive that you can get started straight away – with no software training at all.

Regulation (EU) 2023/1230 on machinery applies from 20 January 2027 and replaces Directive 2006/42/EC (the Machinery Directive) as of that date. Until then, the Machinery Directive continues to apply. The decisive factor is the date on which the machinery is placed on the market: machinery placed on the market before 20 January 2027 is assessed under the Machinery Directive.

As a regulation, the Machinery Regulation applies directly in all EU Member States, without national transposition. The key changes:
The instructions may be provided in digital form (and on request, free of charge, in paper form).
There are updated and new categories of high-risk machinery (Annex I), for some of which the involvement of a notified body is mandatory.
The substantial modification is defined in the legal text for the first time.
There are new requirements for cybersecurity, for software ensuring safety functions, and for machinery with self-evolving behaviour or artificial intelligence.

CE marking is, in principle, a self-declaration by the manufacturer, who bears legal responsibility for ensuring that the product meets the applicable requirements. Involving an external expert is not mandatory. For certain machinery with an increased hazard potential (Annex IV of Directive 2006/42/EC and Annex I of Regulation (EU) 2023/1230 respectively), the involvement of a notified body may be required. Importers and authorised representatives may also be held accountable.

A risk assessment requires you to determine the limits of the machinery, identify hazards across all life-cycle phases, estimate and evaluate the risks, and then reduce them, using the three-step method: first inherently safe design measures, then safeguarding and complementary protective measures, and finally information for use. The process must be repeated iteratively until the residual risk is acceptable, and it must be documented in a traceable manner. The risk assessment is a legal requirement (Directive 2006/42/EC, Annex I, and Regulation (EU) 2023/1230, Annex III respectively).

A substantial modification is a change to machinery made after it has been placed on the market or put into service, by physical or digital means, which the manufacturer did not foresee or plan, and which affects safety by creating a new hazard or increasing an existing risk – for example, where additional guards or protective devices, or additional measures for stability or mechanical strength, become necessary. In that case, the machinery must undergo a new conformity assessment and bear new CE marking. Machinery assembled to function as an integral whole may likewise require a conformity assessment of the assembly as a whole.

An assembly of machinery consists of several machines, or partly completed machinery, that are arranged and controlled in order to achieve the same end, so that they function as an integral whole. Such an assembly requires its own conformity assessment and CE marking as a whole. What matters is the functional connection and the common control of the assembled parts.

Harmonised standards are standards whose references are listed in the Official Journal of the European Union (OJEU) and whose application triggers a presumption of conformity: applying them gives rise to the presumption that the essential health and safety requirements they cover are met. Their application is voluntary, but in practice it is the simplest and safest way to demonstrate conformity. CERTAIN maintains more than 3,000 harmonised standards across eight EU legal acts and continuously, automatically reconciles their references with the Official Journal of the European Union.

For new machinery, the current state of the standards applies; withdrawn standards lose their presumption of conformity. For existing and legacy installations, however, and when assessing a substantial modification, the state of the standards at the time of the original placing on the market may remain relevant. Access to historical, withdrawn standard references is therefore technically relevant – CERTAIN holds both current and withdrawn references.

Yes. Instructions must accompany every machine (Directive 2006/42/EC, Annex I, section 1.7.4; Regulation (EU) 2023/1230, Annex III). Among other things, they must cover the intended use, the reasonably foreseeable misuse, the residual risks, and information on installation, operation and maintenance. Under the Machinery Regulation, the instructions may be provided in digital form; on request, a paper copy must be supplied free of charge.

With the EU declaration of conformity, the manufacturer declares that the machinery complies with the applicable requirements. The mandatory particulars (Directive 2006/42/EC, Annex II, and Regulation (EU) 2023/1230, Annex V respectively) include, among other things, the manufacturer and, where applicable, the authorised representative, the identification of the machinery, the legislation and standards applied, where applicable the notified body, and place, date and signature. The declaration must be drawn up before the machinery is placed on the market and kept, together with the technical documentation, for ten years.

The standards data is not generated by the AI. The standards references come from an official source, the Official Journal of the European Union (OJEU/EUR-Lex), and are continuously and automatically reconciled with it. The AI supports the selection and assignment of the standards relevant to a product. The authoritative reference data comes exclusively from the official source.