Recital (54)

The list of products in Annex IV of Directive 2006/42/EC has until now been based on the risk emanating from the intended use or any reasonably foreseeable misuse of those products or their critical protective function. Nevertheless, the machinery field embraces new ways of designing and constructing machinery or related products that might present higher risk factors, regardless of such intended use or any reasonably foreseeable misuse. For example, systems with self-evolving behaviour ensuring safety functions should be included in Annex I due to their characteristics such as data dependency, opacity, autonomy and connectivity, which might considerably increase the probability and severity of harm and seriously affect the safety of the machinery or related product. Therefore, the conformity assessment of a safety component or a system with self-evolving behaviour ensuring safety functions should be carried out by a third party, whether or not the safety component has been placed independently on the market or is part of a system embedded in machinery that is placed on the market. However, where machinery embeds a system of which the safety component has already been subject to third party conformity assessment when it was placed independently on the market, that machinery should not have to be re-certified by a third party solely on the basis of the embedding of that system.