CE marking is the outcome of a structured conformity assessment process.
We support you with regulatory expertise to ensure that your product can be placed on the market in full legal compliance:
From risk assessment and operating instructions to the final declaration of conformity.
As part of the product categorisation process, we identify precisely which EU regulations are relevant to your project, so that we can establish the correct legal framework from the outset.
Should specific evidence be required, we coordinate or oversee the conduct of product tests to objectively demonstrate compliance with technical limits and safety standards.
We conduct a systematic risk assessment on your behalf, identify potential sources of danger and develop practical solutions to minimise risk.
We simultaneously develop standard-compliant user instructions that ensure safe equipment operation and provide clear guidance to mitigate the risks associated with instructional errors.
In the final phase, we draft the Declaration of Conformity, allowing you to formally confirm that your product meets the regulatory requirements.
CE marking is the final step to bring your product to market and ensure the free movement of goods throughout the EU.
You will need a Declaration of Conformity as soon as your product falls within the scope of one or more pieces of EU harmonisation legislation (e.g. machinery, toys or electronics) and is made available on the European single market. The declaration must be in place before the product is placed on the market or put into service for the first time. Another scenario that is often underestimated arises in the case of a so-called ‘substantial modification’, where existing products are altered so significantly that they are legally considered to be new products and must therefore undergo a completely new conformity assessment procedure.
We conduct a systematic risk assessment on your behalf, identify potential sources of danger and develop practical solutions to minimise risk.
We produce legally compliant user manuals for you that are not only compliant with standards but also user-friendly. By carefully drafting warnings and detailing residual risks, we ensure that your manuals meet all current compliance requirements.
Electrical equipment in accordance with the Low Voltage Directive (2014/35/EU), the EMC Directive (2014/30/EU) and the RoHS Directive (2011/65/EU)
Batteries in accordance with the Battery Regulation (2023/1542)
Machinery in accordance with the Machinery Directive (2006/42/EC) or the new Machinery Regulation (EU 2023/1230)
Radio equipment in accordance with the Radio Equipment Directive (2014/53/EU) and the RoHS Directive (2011/65/EU)
Construction products in accordance with the Construction Products Regulation (EU 305/2011)
Toys in accordance with the Toy Safety Directive (2009/48/EC)
Fertilising products in accordance with the EU Fertilising Products Regulation (EU 2019/1009)
Personal protective equipment in accordance with the PPE Regulation (EU 2016/425)
The CE marking is not a quality mark, but a legally required mark. By affixing it, the manufacturer or their authorised representative makes a legally binding declaration that the product complies with all applicable health and safety requirements set out in the relevant EU harmonisation legislation.
The responsibility lies solely with the manufacturer. If you place products on the market under your own name or brand, these obligations pass to you as the de facto manufacturer.
In most cases, manufacturers are permitted to declare conformity themselves. Only for products of particular safety significance is the involvement of a ‘notified body’ mandatory.
In most cases, the complete technical documentation must be made available to the authorities for at least 10 years from the date on which the last unit of the product was placed on the market.
