The new Product Safety Regulation (EU) 2023/988 makes carrying out a risk assessment mandatory for all products - regardless of whether they are CE-labelled or not. While risk assessments were previously carried out primarily in the context of CE-labelled products, the Product Safety Regulation now explicitly requires that a risk assessment must be carried out by the manufacturer for all products. Companies that place products on the market in the EU under their own name or brand without producing them themselves are also considered ‘manufacturers’ within the meaning of the regulation.
Risk assessment is a systematic process for identifying, evaluating and, if necessary, minimising risks that may be associated with a product throughout its entire life cycle. The aim is to ensure that products do not pose a risk to the health or safety of consumers when used as intended and in a foreseeable manner.
As part of the risk assessment, aspects such as the intended user group, the context of use and possible interactions with other products are taken into account in addition to the product-specific hazards. This holistic approach forms the basis for responsible product development and legally compliant placing on the market.
Our support
asseso supports you in carrying out structured risk assessments - regardless of the product type. We create well-founded risk assessments for individual products or work with you to develop a systematic approach to assess your entire product portfolio efficiently and in compliance with the law. From risk identification and analysis through to complete documentation, we are at your side in an advisory or operational capacity.