Conformity assessment procedure / CE marking [MD, ATEX, PED, LVD]

The conformity assessment procedure is essential to ensure that machines/products and systems meet the safety and health requirements of the European Union. It includes compliance with the applicable directives/regulations such as the Machinery Directive (MD), the ATEX Directive, the Low Voltage Directive (LVD) or the Pressure Equipment Directive (PED). As your competent partner, we will guide you through the entire process – from risk analysis and assessment to supporting external audits.
 

1. Machinery Directive (2006/42/EC)

At the beginning of the process, it is defined whether it is an partly completed machine, a “complete” machine or a assembly of machinery. This is followed by the preparation of a risk assessment according to EN ISO 12100 or the applicable type B and C standards, in order to identify possible hazards and to propose standard-compliant countermeasures. After that, the technical documentation – either the assembly instructions for partly completed machinery or the operating instructions for complete machinery – is checked. Finally, the sample declaration of incorporation (for partly completed machinery) or the sample declaration of conformity (for machinery) is issued, which you as the manufacturer sign so that the CE marking can be affixed.

 Attention: The new Machinery Regulation (EU) 2023/1230 is to be applied from January 20, 2027. Learn more about this in our training courses!
 

2. ATEX Product Directive (2014/34/EU)

The ATEX Directive covers products that are used in potentially explosive atmospheres. The Directive differentiates between devices, protective systems, components and safety, control and regulating devices. If the product is subject to the ATEX Directive, a risk analysis and assessment (ignition source analysis/ignition hazard assessment) is carried out to identify potential ignition sources and to suggest appropriate protective measures that comply with the standards. The technical documentation, including the operating instructions, is then checked. Finally, the sample attestation of conformity (for components) or the sample declaration of conformity (for devices, protective systems and safety, control and regulating devices) is created, which you as the manufacturer sign to confirm ATEX conformity and to affix the CE marking.
 

3. Low Voltage Directive (2014/35/EU)

The Low Voltage Directive (LVD) applies to electrical devices in the voltage range of 50 to 1,000 volts (alternating current) and 75 to 1,500 volts (direct current). The first step is to check whether the product falls under the LVD. This is followed by a risk analysis to identify hazards such as short circuits, overloading or insulation faults. Protective measures such as insulation, protective earthing and shut-off devices are evaluated in accordance with EN 60204-1, among other things. The technical documentation is then created or checked and the sample conformity declaration and CE marking are issued.
 

4. Pressure Equipment Directive (2014/68/EU)

The Pressure Equipment Directive (PED) applies to devices and assemblies that are operated at a maximum allowable pressure greater than 0.5 bar, such as pressure vessels, piping and safety valves. The first step is to determine whether the product is covered by the directive. This is followed by a risk analysis and assessment to identify hazards from events such as overpressure, underpressure or material failure, etc. Protective measures such as safety valves, pressure controls and suitable materials are evaluated. The technical documentation includes strength calculations, material certificates and operating instructions. Finally, the declaration of conformity is created and the CE marking is applied.
 

5. Product Safety Regulation (EU) 2023/988

The new Product Safety Regulation (EU) 2023/988 is to be applied from December 13, 2024 and replaces the previous General Product Safety Directive 2001/95/EC. This regulation applies in whole or in part to almost all consumer products placed on the EU market, including electronics, toys, household appliances, and repaired and refurbished products. It requires manufacturers to carry out a risk analysis and assessment and to take appropriate protective measures to ensure product safety, as well as to provide clear instructions and safety information. In addition, companies must implement traceability measures to be able to carry out recall actions in accordance with the new requirements.