Summary

A manufacturer under the CRA is an entity that produces products with digital elements. This includes entities that make substantial modifications to such products and place them on the market. Importers and distributors may also be considered manufacturers under specific conditions.

Relevant CRA Provisions

– Recital 35, Recital 53, Recital 78, Recital 94
– Article 12, Article 18, Article 21, Article 22

Detailed Explanation

Under the CRA, a manufacturer is primarily defined as the entity that produces products with digital elements. However, the definition extends to include other entities under certain conditions:
– Substantial Modifications: Any natural or legal person, other than the original manufacturer, importer, or distributor, that carries out a substantial modification of a product with digital elements and makes that product available on the market, is considered a manufacturer for the purposes of this Regulation (Article 22).
– Importers and Distributors: An importer or distributor shall be considered a manufacturer where they place a product with digital elements on the market under their name or trademark or carry out a substantial modification of a product already on the market (Article 21).

Additionally, entities operating under new business models linked to online sales may fall into different categories of economic operators depending on the nature of the services they provide (Recital 78).

Obligations for Stakeholders

– Manufacturers: Must comply with the essential cybersecurity requirements, ensure conformity assessment, and maintain relevant documentation (Articles 12, 18).
– Entities Making Substantial Modifications: Subject to the obligations set out in Articles 13 and 14 for the part of the product affected by the modification (Article 22).
– Importers and Distributors: May be subject to manufacturer obligations if they place products on the market under their name or make substantial modifications (Article 21).