Machinery Safety (CE) Certification

The Machinery Safety legislation sets the essential health and safety requirements to be met in the design and manufacture of machinery placed on the EU market. Directive 2006/42/EC was in force for many years; it has been replaced by the directly applicable Machinery Regulation (EU) 2023/1230, which will apply from 20 January 2027. Risk assessment sits at the centre of the legislation: the manufacturer must assess and reduce risks for the machinery's foreseeable use and reasonably foreseeable misuse.

• Manufacturers of machinery, machine lines and interconnected machinery
• Firms manufacturing partly completed machinery
• Manufacturers of safety components, lifting accessories, chains and ropes
• Importers who import machinery and place it on the market under their own name
• Businesses making a substantial modification to existing machinery

Mandatory for machinery within scope; it cannot be placed on the EU market without the CE mark. Notified-body involvement is not mandatory for every machine: a notified body is involved for products on the legislation's high-risk machinery list (e.g. certain woodworking machines, presses, personnel-lifting equipment); for machinery not on the list, the manufacturer can self-declare through internal production control.

• Scope and definitions: machinery, partly completed machinery, safety component, lifting accessory
• Essential health and safety requirements (Annex III): materials, lighting, control systems, mechanical hazards, guards
• The safety of control systems and the performance level of safety functions
• Protection against moving parts and electrical and thermal hazards
• Reduction of noise, vibration and emissions
• Additional requirements for lifting, portability and specific machinery categories
• Risk assessment and the risk-reduction hierarchy: elimination by design, guards and measures, informing the user
• Instructions for use, warnings and marking requirements
• Conformity-assessment modules and the high-risk machinery list
• The content of the technical file and the EU Declaration of Conformity

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• General-arrangement drawings and control-circuit diagrams
• The risk assessment document and the measures taken
• The list of harmonised standards applied (e.g. EN ISO 12100)
• Calculations for safety functions (PL/category under EN ISO 13849-1)
• The instructions for use and a sample of the machine's rating plate

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CELVD
• CEEMC
• CERED
• CEMDR
• CEIVDR
• CEPED
• CESPVD
• CEATEX